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Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Proposed Rules
Issued in College Park, Georgia, on
November 2, 2022.
Andreese C. Davis,
Manager, Airspace & Procedures Team South,
Eastern Service Center, Air Traffic
Organization.
effective September 15, 2022, is
amended as follows:
Paragraph 5000
Class D Airspace.
*
*
*
*
ASO GA D
*
Athens, GA [Amended]
Athens/Ben Epps Airport, Athens, GA
(Lat. 33°56′55″ N, long. 83°19′33″ W)
That airspace extending upward from the
surface to and including 3,300 feet MSL
within a 4.6-mile radius of the Athens/Ben
Epps Airport. This Class D airspace area is
effective during the specified dates and times
established in advance by a Notice to Air
Missions. The effective date and time will
thereafter be continuously published in the
Chart Supplement.
Paragraph 6002
Class E Surface Airspace.
*
*
*
*
ASO GA E2
*
Athens, GA [Amended]
Athens/Ben Epps Airport, Athens, GA
(Lat. 33°56′55″ N, long. 83°19′33″ W)
That airspace extending upward from the
surface within a 4.6-mile radius of the
Athens/Ben Epps Airport. This Class E
airspace area is effective during the specific
dates and times established in advance by a
Notice to Air Missions. The effective date
and time will thereafter be continuously
published in the Chart Supplement.
Paragraph 6004 Class E Airspace
Designated as an Extension to Class D
Surface Area.
*
*
*
ASO GA E4
*
*
Athens, GA [Amended]
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Athens/Ben Epps Airport, Athens, GA
(Lat. 33°56′55″ N, long. 83°19′33″ W)
(Athens Point of Origin)
(Lat. 33°56′51″ N, long 83°19′29″ W)
That airspace extending upward from the
surface within 2.4 miles on each side of the
Athens Point of Origin 195° bearing
extending from the 4.6-mile radius of the
Athens/Ben Epps Airport to 7.6 miles south
of the Point of Origin, and within 1.4 miles
each side of the Athens Point of Origin 076°
bearing extending from the 4.6-mile radius of
the airport to 7 miles east of the Point of
Origin. This Class E airspace area is effective
during the specific dates and times
established in advance by a Notice to Air
Missions. The effective date and time will
thereafter be continuously published in the
Chart Supplement.
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
*
ASO GA E5
*
*
Athens, GA [Amended]
Athens/Ben Epps Airport, GA
(Lat. 33°56′55″ N, long. 83°19′33″ W)
That airspace extending upward from 700
feet above the surface within a 7.7-mile
radius of Athens/Ben Epps Airport.
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[FR Doc. 2022–24348 Filed 11–8–22; 8:45 am]
BILLING CODE 4910–13–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1270
[CPSC Docket No. CPSC–2013–0022]
Safety Standard for Adult Portable Bed
Rails
Consumer Product Safety
Commission.
ACTION: Notice of proposed rulemaking;
notice of opportunity for oral
presentation of comments.
AGENCY:
The U.S. Consumer Product
Safety Commission (Commission or
CPSC) has determined preliminarily
that there is an unreasonable risk of
injury and death associated with
entrapment hazards from adult portable
bed rails (APBRs). To address these
risks, the Commission proposes a rule
under the Consumer Product Safety Act
(CPSA) to require that APBRs meet the
requirements of the applicable
voluntary standard on APBRs, with
modifications. The Commission is
providing an opportunity for interested
parties to present written and oral
comments on this notice of proposed
rulemaking (NPR). Like written
comments, any oral comments will be
part of the rulemaking record.
DATES:
Deadline for Written Comments:
Written comments must be received by
January 9, 2023.
Deadline for Request to Present Oral
Comments: Any person interested in
making an oral presentation must send
an electronic mail (email) indicating
this intent to the Office of the Secretary
at cpsc-os@cpsc.gov by December 9,
2022.
ADDRESSES:
Written Comments: Comments related
to the Paperwork Reduction Act aspects
of the instructional literature and
marking requirements of the proposed
rule should be directed to the Office of
Information and Regulatory Affairs,
OMB, Attn: CPSC Desk Officer, FAX:
202–395–6974, or emailed to oira_
submission@omb.eop.gov. In addition,
written comments that are sent to OMB
also should be submitted electronically
at: www.regulations.gov, under Docket
No. CPSC–2013–0022.
SUMMARY:
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Other comments, identified by Docket
No. CPSC–2013–0022, may be
submitted by any of the following
methods:
Electronic Submissions: Submit
electronic comments to the Federal
eRulemaking Portal at:
www.regulations.gov. Follow the
instructions for submitting comments.
CPSC typically does not accept
comments submitted by email, except as
described below. CPSC encourages you
to submit electronic comments by using
the Federal eRulemaking Portal, as
described above.
Mail/Hand Delivery/Courier Written
Submissions: Submit comments by
mail/hand delivery/courier to: Office of
the Secretary, Consumer Product Safety
Commission, 4330 East West Highway,
Bethesda, MD 20814; telephone: (301)
504–7479. If you wish to submit
confidential business information, trade
secret information, or other sensitive or
protected information that you do not
want to be available to the public, you
may submit such comments by mail,
hand delivery, or courier, or you may
email them to: cpsc-os@cpsc.gov.
Instructions: All submissions must
include the agency name and docket
number. CPSC may post all comments
without change, including any personal
identifiers, contact information, or other
personal information provided, to:
www.regulations.gov. Do not submit
through this website: confidential
business information, trade secret
information, or other sensitive or
protected information that you do not
want to be available to the public. If you
wish to submit such information, please
submit it according to the instructions
for mail/hand delivery/courier written
submissions.
Docket for NPR: For access to the
docket to read background documents
or comments received, go to:
www.regulations.gov, insert the docket
number CPSC–2013–0022 into the
‘‘Search’’ box, and follow the prompts.
FOR FURTHER INFORMATION CONTACT:
Vineed Dayal, Directorate for
Engineering Sciences, Office of Hazard
Identification and Reduction, Consumer
Product Safety Commission, National
Product Testing and Evaluation Center,
5 Research Place, Rockville, MD 20850;
telephone: 301–987–2292; vdayal@
cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
In 2013, the CPSC received two
requests to initiate proceedings under
the CPSA to address an unreasonable
risk of injury associated with APBRs.
Gloria Black, the National Consumer
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Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Proposed Rules
Voice for Quality Long-Term Care,
Consumer Federation of America, and
60 other organizations made one
request; Public Citizen Health Research
Group made the other request.
Collectively, the petitioners stated that
many of the deaths and injuries
involving APBRs result from
asphyxiation caused by entrapment
within openings of the APBR rail or
between the rail and the mattress or bed
frame. The petitioners requested that the
CPSC initiate proceedings under section
8 of the CPSA to ban all APBRs.
Alternatively, petitioners requested that
the Commission initiate a rulemaking
under section 9 of the CPSA to
promulgate mandatory standards,
including warning labels, to reduce the
unreasonable risk of asphyxiation and
entrapment posed by APBRs. Petitioners
also requested action under section
27(e) of the CPSA to require
manufacturers of APBRs to provide
performance and technical data
regarding the safety of their products.
The CPSC docketed the requests as a
single petition: Petition CP 13–1,
Petition Requesting a Ban or Standard
on APBRs under the CPSA. On June 4,
2013, the Commission published a
notice in the Federal Register seeking
public comment concerning the petition
(78 FR 33393). Also in 2013, ASTM
International (ASTM) formed the ASTM
F15.70 subcommittee to begin
developing a voluntary standard for
APBRs. On April 23, 2014, staff
delivered a briefing package to the
Commission (Staff’s 2014 briefing
package).1 In that briefing package, staff
responded to the comments received on
the petition and recommended that the
Commission defer a decision on the
petition to allow the voluntary
standards process to continue until the
APBR standard had been developed and
evaluated by staff. On April 29, 2014,
the Commission voted to defer the
petition to allow progress to continue on
the voluntary standard.
On April 28, 2015, the Commission
voted again to defer a decision on the
petition to allow the ASTM voluntary
standard development process to
continue. Throughout this period, staff
participated in the ASTM F15.70
subcommittee to develop the voluntary
standard for APBRs. In August 2017,
ASTM published the voluntary
standard, ASTM F3186–17, Standard
Specification for Adult Portable Bed
Rails and Related Products.
On July 15, 2020, staff provided the
Commission a briefing package on its
1 Available
at: https://www.cpsc.gov/s3fs-public/
pdfs/foia_PetitionCP131RequestforBanor
StandardforAdultPortableBedRail.pdf.
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review of ASTM F3186–17 (Staff’s 2020
briefing package).2 Staff’s review
indicated that ASTM F3186–17, with
certain modifications to the labeling,
warning statements, and instructional
literature, would adequately address the
hazards identified in the known
incident reports. However, when staff
assessed compliance to the voluntary
standard, as discussed in section IV.B.
of this preamble, staff found no market
compliance with the voluntary
standard. To increase market awareness
of and compliance with the voluntary
standard, in June 2020, CPSC’s Office of
Compliance sent a letter to 19 known
APBR manufacturers, urging industry
members to stop manufacturing,
distributing, and selling APBRs that do
not comply with ASTM F3186–17. Staff
also continued to engage actively with
the ASTM F15.70 subcommittee
meetings. Staff presented and explained
its testing results to the subcommittee
members, provided the subcommittee
with Compliance’s letter to industry for
all its members to review and
disseminate, supplied updated incident
data for the subcommittee’s review, and
participated as technical experts at all
subcommittee task groups.
On March 9, 2022, staff provided to
the Commission another briefing
package on ASTM F3186–17 (Staff’s
2022 briefing package).3 Staff’s 2022
briefing package updated the Staff’s
2020 briefing package with incident
data that included all known APBR
incidents from January 2003 through
September 2021. In addition, staff
discussed the results of the two rounds
of testing it had conducted on APBRs,
and whether there was any change in
the levels of compliance in the APBR
market. Staff recommended that the
Commission grant the petition and
direct staff to prepare a briefing package
and initiate rulemaking through a notice
of proposed rulemaking (NPR) to
address the entrapment hazards
associated with APBRs.
On March 16, 2022, the Commission
voted to grant Petition CP 13–1 and
directed staff to proceed with this NPR.
In this proposed rule, the Commission
preliminarily determines that APBRs
pose an unreasonable risk of injuries
and deaths associated with entrapment
hazards.4 As discussed in section V. of
2 Available at: https://www.cpsc.gov/s3fs-public/
Update%20on%20Peititon%20CP%2013-1%20%20Requesting%20a%20Ban%20or%20Mandatory
%20Standard%20on%20Adult%20Portable
%20Bed%20Rails.pdf?kiDixW5Z7x9xcOqjx
SeS3QpvspdfQMBY.
3 Available at: https://www.cpsc.gov/s3fs-public/
Petition-Requesting-a-Ban-or-Standard-on-AdultPortable-Bed-Rails-Petition-CP-13-1.pdf.
4 The Commission voted 4–0 to approve this
document.
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this preamble, the Commission
preliminarily determines that the
voluntary standard is not likely to
eliminate or adequately reduce the
unreasonable risk of injury associated
with entrapments on APBRs.
Accordingly, the Commission is
proposing to adopt the voluntary
standard with specified modifications
necessary to improve safety and
adequately reduce the unreasonable risk
of injury associated with entrapment on
APBRs. The information discussed in
this preamble is derived primarily from
CPSC staff’s briefing package for the
NPR (Staff’s NPR briefing package).5
This proposed rulemaking is
authorized by the CPSA. 15 U.S.C.
2051–2084. Section 7(a) of the CPSA
authorizes the Commission to
promulgate a mandatory consumer
product safety standard that sets forth
performance or labeling requirements
for a consumer product, if such
requirements are reasonably necessary
to prevent or reduce an unreasonable
risk of injury. 15 U.S.C. 2056(a). Section
9 of the CPSA specifies the procedure
that the Commission must follow to
issue a consumer product safety
standard under section 7 of the CPSA.
In accordance with section 9, the
Commission is commencing this
rulemaking by issuing an NPR.
According to section 9(f)(1) of the
CPSA, before promulgating a consumer
product safety rule, the Commission
must consider, and make appropriate
findings to be included in the rule, on
the following issues:
• The degree and nature of the risk of
injury that the rule is designed to
eliminate or reduce;
• The approximate number of
consumer products subject to the rule;
• The need of the public for the
products subject to the rule and the
probable effect the rule will have on
utility, cost, or availability of such
products; and
• The means to achieve the objective
of the rule while minimizing adverse
effects on competition, manufacturing,
and commercial practices.
Id. 2058(f)(1)
Under section 9(f)(3) of the CPSA, to
issue a final rule, the Commission must
find that the rule is ‘‘reasonably
necessary to eliminate or reduce an
unreasonable risk of injury associated
with such product’’ and that issuing the
rule is in the public interest. Id.
2058(f)(3)(A)&(B). Additionally, if a
5 Available at: https://www.cpsc.gov/s3fs-public/
ProposedRuleSafetyStandardforAdultPortableBed
Rails.pdf?VersionId=Ypa89Iczh13C40Tq7EJRSMD
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Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Proposed Rules
voluntary standard addressing the risk
of injury has been adopted and
implemented, the Commission must
find that:
• The voluntary standard is not likely
to eliminate or adequately reduce the
risk of injury, or
• Substantial compliance with the
voluntary standard is unlikely.
Id. 2058(f)(3)(D). The Commission
also must find that expected benefits of
the rule bear a reasonable relationship
to its costs and that the rule imposes the
least burdensome requirements that
would adequately reduce the risk of
injury. Id. 2058(f)(3)(E)&(F).
II. Product Description
There are several types of bed rails
available to consumers under CPSC
jurisdiction.6 ASTM F3186–17 (section
1.2) describes ‘‘portable bed rails and
related products’’ as products installed
by consumers and ‘‘not designed as part
of the bed by the bed manufacturer.’’
Generally, APBRs within CPSC’s
jurisdiction include products that are
installed or used alongside of a bed by
consumers and are intended to reduce
the risk of falling from the bed, assist
the consumer in repositioning in the
bed, or assist the consumer in
transitioning into or out of the bed.
Figure 1 below shows four types of bed
rails.
(Tab A: Division of Hazard Analysis:
Directorate for Epidemiology (EPHA)).
Staff reviewed Consumer Product Safety
Risk Management System (CPSRMS)
injury cases and National Electronic
Injury Surveillance System (NEISS)
injury cases that occurred in the period
from January 1, 2003, through December
31, 2021.
Although similar in design, these
products may have different functions.
Some are meant to keep the occupant
from rolling out of bed, and others are
intended to assist an occupant in getting
in and out of bed or repositioning on the
bed surface. Some of these products can
serve both functions. Because of the
similarity in design and means of
attachment to the side of the bed,
products intended for both types of uses
can have the same potential entrapment
hazards, as discussed in section III of
this preamble.
In September and October 2021, CPSC
staff conducted an online search that
identified 12 firms supplying 65 distinct
APBR models. Retail prices for the
identified APBR models ranged from
$38 to $275. Based on an interview with
one APBR manufacturer’s representative
and market information from the
identified APBR models, staff estimates
that in 2021, the mean retail price is $50
per APBR; total market revenues are
approximately $9 million; and the
number of APBRs sold that year was
approximately 180,000 units.
CPSC staff summarized the data on
deaths and injuries involving APBRs
Staff identified a total of 332 incident
reports for the period January 2003 to
December 2021. Of these, 310 were
reports of fatalities, and 22 were reports
of nonfatal incidents. Most of the
6 Information on adult bed rails regulated by the
U.S. Food and Drug Administration (FDA)
jurisdiction is available at: www.fda.gov/medicaldevices/bed-rail-safety/safety-concerns-about-bedrails. FDA regulations do not reference ‘‘bed rails’’
or ‘‘bed handles’’; rather, FDA regulations refer to
‘‘movable and latchable side rails.’’ See 21 CFR
880.5100, 880.5110, 880.5120. The FDA regulates
adjustable hospital beds used for medical purposes.
Bed rails that are an accessory or appurtenance to
regulated hospital beds are considered by the FDA
to have a medical purpose and to be devices subject
to FDA jurisdiction. APBR intended for use with a
non-FDA regulated bed and that are not considered
by the FDA to have a medical purpose fall under
the CPSC’s jurisdiction. These types of bed rails are
within the CPSC’s jurisdiction regardless of the
bed’s location (i.e., long-term care facility, hospice,
or residence). ASTM F3186–17 (section 1.3) covers
both APBRs that meet the definition of a medical
device under FDA’s jurisdiction, and APBRs that
are not medical devices, and fall under CPSC’s
jurisdiction pursuant to the CPSA.
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III. Risk of Injury
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A. CPSRMS
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Figure 1: General examples of APBR types - (1) Full-Length Bed Rail, (2) Bed Cane, (3) Bed Handle, and (4) HalfLength Bed Rail
Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Proposed Rules
incidents were identified from death
certificates, medical examiner reports,
or coroner reports. Death certificate data
often have lag time of around two to
three years from date of reporting. As
the APBR data in CPSRMS are heavily
reliant on death certificates, data
collection is ongoing and incident data
for 2020, 2021, and 2022 should all be
considered incomplete, and likely to
increase.
The remaining incidents were
extracted from various sources
including newspaper clippings,
consumer reports, and manufacturer
and retailer reports to CPSC. These
documents contain limited information
on incident scenarios. The age range of
67589
victims in the 305 fatal incidents for
which age was reported was 14 to 103
years. More than 75 percent of the
incident victims were age 70 or older,
and almost 80 percent of the reported
fatalities involved victims ages 70 or
older. Table 1 below presents the
distribution of these APBR incidents by
age.
TABLE 1—DISTRIBUTION OF REPORTED APBR-RELATED INCIDENTS BY AGE
Age group
(years)
Fatalities
Nonfatalities
Total
13–29 ...........................................................................................................................................
30–59 ...........................................................................................................................................
60–69 ...........................................................................................................................................
70–79 ...........................................................................................................................................
80–89 ...........................................................................................................................................
90 or older ...................................................................................................................................
Unknown/Unspecified ..................................................................................................................
7
30
22
47
124
75
5
0
0
0
2
2
1
17
7
30
22
49
126
76
22
Total ......................................................................................................................................
310
22
332
Source: CPSRMS (2003–2021).
Table 2 details the distribution of
these APBR-related incidents by gender.
Approximately 70 percent of all
incident victims and incident fatalities
were female.
TABLE 2—DISTRIBUTION OF REPORTED APBR-RELATED INCIDENTS BY GENDER
Gender
Fatalities
Nonfatalities
Total
Male .............................................................................................................................................
Female .........................................................................................................................................
Unknown/Unspecified ..................................................................................................................
88
221
1
7
8
7
95
229
8
Total ......................................................................................................................................
310
22
332
Source: CPSRMS (2003–2021).
Approximately 50 percent of all
APBR-related incidents and fatalities
occurred at home. Other commonly
reported locations included nursing
homes, assisted living facilities, and
residential institutions, for example.7
Table 3 below shows the frequency of
each location reported.
TABLE 3—DISTRIBUTION OF REPORTED APBR-RELATED INCIDENTS BY LOCATION
Location
Fatalities
Nonfatalities
Total
Home ...........................................................................................................................................
Nursing Home ..............................................................................................................................
Assisted Living Facility ................................................................................................................
Residential Institution ...................................................................................................................
Other * ..........................................................................................................................................
Unknown/Not Reported ...............................................................................................................
158
50
40
14
23
25
6
0
2
0
0
14
164
50
42
14
23
39
Total ......................................................................................................................................
310
22
332
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Source: CPSRMS (2003–2021).
* Includes care home/center, foster home, group home, retirement center, adult family home and hospice.
The majority of reports, 58 percent,
indicated that the victim suffered from
at least one underlying medical
condition. Almost 34 percent were
reported to have more than one medical
condition. Table 4 below summarizes
the most common underlying medical
conditions reported.
7 All of these reported incidents occurred with
APBRs that fall under the CPSC’s jurisdiction.
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Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Proposed Rules
TABLE 4—DISTRIBUTION OF REPORTED APBR-RELATED INCIDENTS BY MEDICAL CONDITION * +
Condition
Fatalities
Cardiovascular disease ...............................................................................................................
Alzheimer’s/Dementia/Mental ......................................................................................................
Mobility/Paralysis/Stroke ..............................................................................................................
Parkinson’s disease .....................................................................................................................
Pulmonary disease ......................................................................................................................
Cancer .........................................................................................................................................
Cerebral palsy ..............................................................................................................................
Multiple sclerosis .........................................................................................................................
Other * ..........................................................................................................................................
Unknown/Not Reported ...............................................................................................................
Nonfatalities
87
73
20
17
10
7
6
5
20
123
Total
0
0
0
1
0
0
0
0
0
21
87
73
20
18
10
7
6
5
20
144
Source: CPSRMS (2003–2021).
* Other significant conditions included tracheotomy and G-tube, severe burn, post-surgery, fracture, seizure, Lesch-Nyhan syndrome,
amyotrophic lateral sclerosis, multiple drug ingestion, renal disease, agitation, diabetes, sepsis, leukemia, severe disabilities, advanced age, and
general weakness.
+ Table 4 sums to more than 332 due to multiple conditions reported.
B. NEISS
Between January 2003 and December
2021, there were an estimated 79,500
injuries related to adult bed rails treated
in hospital emergency departments
(EDs) across the United States. There
appeared to be a statistically significant
increasing trend in injuries during this
period. Staff’s review showed that in the
vast majority of NEISS cases, there was
insufficient information available in the
case narrative to determine whether the
bed rail product involved was
specifically an adult portable bed rail, or
just a regular adult bed rail; only one
case narrative specifies the product
involved as an adult portable bed rail.
Hence, the estimates presented in Table
5, which provides an overview of the
estimated number of adult bed railrelated injuries per year, may be an
overestimate. An estimated injury rate
per 100,000 population has also been
calculated, based on estimates of
population ages 13 and older provided
by the U.S. Census Bureau.
TABLE 5—NEISS ESTIMATES FOR INJURIES RELATED TO ADULT BED RAILS, JANUARY 2003–DECEMBER 2021
Estimate 8
Year
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
Sample size
Injury rate 9
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
4,500
3,400
3,900
3,400
4,300
4,200
3,600
4,000
3,700
3,100
4,700
4,400
4,600
3,700
4,900
4,300
4,500
5,100
5,100
98
82
94
72
98
102
98
100
95
81
127
108
112
91
128
104
112
113
131
1.88
1.39
1.61
1.38
1.73
1.67
1.42
1.56
1.44
1.20
1.79
1.66
1.73
1.36
1.81
1.55
1.63
1.82
1.83
Total ......................................................................................................................................
79,500
1,946
........................
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Source: NEISS (2003–2021). Estimates rounded to nearest 100; rows may not add to total due to rounding.
The vast majority (88 percent) of
patients were treated and released or
examined and released without
treatment, while approximately 11
percent were hospitalized or held for
observation. There was only one NEISS
case that involved a death; the
remaining 1,945 involving nonfatal
injuries. This one NEISS case involving
a death is separate from any of the
CPSRMS incidents, and it was unclear
what specific type of product was
involved.
C. Hazard Patterns
8 According to the NEISS publication criteria, an
estimate must be 1,200 or greater, the sample size
must be 20 or greater, and the coefficient of
variation must be 33 percent or smaller. All yearly
estimates meet these criteria, and thus, are
reportable.
9 Obtained by dividing NEISS estimates by U.S.
Census Bureau population estimate for the
respective year (for ages 13+). Latest data can be
found here: National Population by Characteristics:
2020–2021 (census.gov), https://www.census.gov/
data/tables/time-series/demo/popest/2020snational-detail.html.
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Staff from CPSC’s Directorate for
Health Sciences (HS) and from the
Human Factors Division of the
Directorate for Engineering Sciences
(ESHF) (Tabs B and C of Staff’s NPR
briefing package) reviewed the incident
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data to assess the affected population
and the hazard modes associated with
incidents involving APBRs. Staff found
that the vast majority of incident victims
in CPSRMS were members of vulnerable
populations.
• More than 75 percent of the victims
were age 70 or older.
• More than 80 percent of the
reported fatalities involved victims ages
70 or older.
• Fifty-eight percent of victims
suffered from at least one underlying
medical condition.
• Almost 34 percent of victims were
reported to have more than one medical
condition.
Staff grouped the hazard types into
four categories based on the bed rail’s
role in the incident. The categories are
listed in order of highest to lowest
frequency.
• Rail entrapment: There were 286
incidents related to rail entrapment.
This category includes incidents in
which the victim was caught, stuck,
wedged, or trapped between the
mattress/bed and the bed rail, between
bed rail bars, between a commode and
rail, between the floor and rail, between
the night table and rail, or between a
dresser and rail. Based on the narratives,
the most frequently injured body parts
were the neck and head. This category
includes 284 fatalities and two nonfatal
injuries from entrapment or wedging
between the bed rail and mattress.
• Falls: There were 25 incidents
related to falls. This category includes
incidents in which the victim fell off the
bed, fell and hit the bed rail, or hit and
fell near the bed rail, and fell after
climbing over the bed rail. This category
includes 23 deaths, one nonfatal knee
fracture and one non-injury incident.
• Structural integrity: There were 11
incidents related to structural
component problems (weld of bed rail
broke and bed rail not sturdy). This
category includes one laceration, one
head bump, one bruise, two unspecified
injuries, and six non-injury incidents.
• Miscellaneous: There were 10
incidents with miscellaneous problems
(hanging on the bed rail after garment
got caught, hand, arm or leg laceration,
pinched radial nerve against the bed
rail, complaint about a misleading label,
complaint about a bed rail that was
noncompliant with the ASTM standard,
and a claim against a bed rail
manufacturer about an unspecified
issue). This category includes three
deaths, three lacerations, one pinched
nerve, one unspecified injury, and two
non-injury incidents.
Rail entrapment, the most common
hazard pattern among all reported
incidents, accounted for more than 90
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percent (284 of 310) of the fatal
incidents. A review of the In-Depth
Investigations (IDIs) 10 confirmed that
APBRs product types, like those shown
in Figure 1, were involved in these
entrapment incidents. The victim was
typically found with their torso between
the product and the mattress frame,
with their neck resting on the lower bar.
Three other hazard patterns were also
reported: (1) chin resting on the bar; (2)
patient slumped backwards, partially
suspended with the thorax lodged and
compressed in the gap between the rail
and mattress; and (3) slumped through
the bar opening. The medical examiners
in these cases listed the causes of death
as ‘‘positional asphyxia,’’ with an
additional list of ‘‘underlying factors’’ or
‘‘contributory causes.’’ Staff’s analysis of
the data revealed that the head and neck
were the body parts most frequently
entrapped, with positional asphyxia
(neck against rail) identified as the most
common cause of death. Sustained
external pressure on the neck can lead
to ‘‘asphyxia,’’ defined in medical
literature as the failure of cells to thrive
in the absence of oxygen. Neck
compression, with or without airway
blockage, can result in death, even when
the body remains partially supported,
because blood vessels taking blood to
and from the brain and the carotid
sinuses are located in soft tissues of the
neck and are relatively unprotected.
Of the 310 fatal incidents,
approximately 34 percent reported the
victim to have multiple medical
conditions, and approximately 58
percent of incidents reported at least
one underlying medical condition. The
vast majority of nonfatal incident
reports (all reports except one) did not
list any underlying medical condition.
Preexisting chronic medical conditions
or disorders included Alzheimer’s
disease, dementia, and other mental
limitations; Parkinson’s disease;
cerebral palsy; multiple sclerosis; LeschNyhan syndrome;11 amyotrophic lateral
sclerosis; cancer; cardiovascular disease;
and pulmonary disease. Other
conditions included victims with stroke,
paralysis, seizures, heavy sedation, and
drug ingestion. These factors can limit
mobility or mental acuity and contribute
to the risk of death by entrapment,
because individuals with these
conditions are particularly vulnerable
and often cannot respond to the danger
and free themselves. As discussed in
10 IDIs contain summaries of reports of
investigations into events surrounding productrelated injuries or incidents based on victim/
witness interviews.
11 A rare genetic disease characterized by
neurological and behavioral abnormalities and
occurs almost exclusively in males.
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Tab B of the Staff’s NPR briefing
package, adult aging issues can
contribute to entrapments, including
age-related declines in muscular
strength, muscular power, motor control
and coordination, and balance.
Consumers 70 years and older, who
represent the victims in most APBRrelated fatalities, are especially
vulnerable to such declines. Also,
consumers commonly purchase and use
APBRs because they require help when
getting in or out of bed. Therefore, many
APBR users would likely be less capable
of escaping an entrapment scenario than
the general population.
CPSC staff identified falls as the
second most common hazard pattern
associated with APBRs, accounting for
25 incidents (8 percent), 23 of which
resulted in fatality. Staff found that most
falls associated with APBRs involve the
victim falling against or striking the
APBR, but these incident reports
usually have limited details. Therefore,
the APBRs might have played an
incidental role in some of these cases.
A minority of fall-related incidents,
according to staff’s review, involved the
victim deliberately climbing over the
APBR.
IV. ASTM F3186–17
To issue a final rule under section
9(f)(3) of the CPSA if a voluntary
standard addressing the risk of injury
has been adopted and implemented, the
Commission must find that:
• The voluntary standard is not likely
to eliminate or adequately reduce the
risk of injury, or
• Substantial compliance with the
voluntary standard is unlikely.
Based on staff’s review of ASTM
F3186–17, the Commission has
preliminarily determined that the
voluntary standard is not likely to
eliminate or adequately reduce the
unreasonable risk of injury associated
with entrapments on APBRs. In
addition, based on several rounds of
testing of APBRs, conducted by staff as
discussed below, the Commission has
preliminarily determined that
substantial compliance with the
voluntary standard is also unlikely.
Accordingly, in this rule, the
Commission proposes to incorporate by
reference ASTM F3186–17, with
modifications, to address the
entrapment hazards associated with
APBRs. CPSC staff’s assessment of the
provisions of ASTM F3186–17 are
summarized below.
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A. Assessment of ASTM F3186–17
Performance Requirements
1. Terminology
ASTM F3186–17 establishes
performance requirements for APBRs,
including requirements for resistance to
entrapment, marking and labeling, and
instructional literature. Section 3.1.1 of
ASTM F3186–17 defines ‘‘adult portable
bed rail’’ as:
[A]n adjacent type bed rail, grab bar,
assistive bar, transfer aid, cane or rail
(henceforth identified as the product or
products) intended by the manufacturer to be
installed on, against, or adjacent to an adult
bed. The product may vary in lengths (for
example, full, half, or partial rails, grab bar
or handle or transfer post or pole), and is
intended by the manufacturer to aid the bed
occupant in moving on the bed surface, in
entering or exiting the bed, to minimize the
possibility of falling out of bed, or for other
similar purposes. This includes similar
products that are likely to be used for these
purposes even if this is not explicitly stated
by the manufacturer. However, the standard
does not address all products that might be
so used, for example, a chair.
ASTM F3186—17 (section 3.1.2)
defines ‘‘adjacent type bed rail’’ as:
[A] portable bed rail or related product in
which the guard portion (portion that an
adult would contact when rolling toward the
mattress edge) is essentially a vertical plane
or pole that is positioned against the side of
the mattress.
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The Commission preliminarily
determines that these definitions are
appropriate for evaluating APBRs that:
(1) are installed or used along the side
of a bed and intended to reduce the risk
of falling from the bed; (2) assist the
consumer in repositioning in the bed; or
(3) assist the consumer in transitioning
into or out of the bed.
2. General Requirements
Section 5 of ASTM F3186–17 sets out
general requirements. Section 5.1
requires that there will be no hazardous
sharp points or edges. Section 5.2 states
that any exposed parts shall be smooth
and free from rough edges. Section 5.3
requires that products covered by the
standard that are installed on a bed that
articulates (i.e., is adjustable) must meet
the performance requirements when the
bed is in the flat and articulated
positions.
General requirements mandating
smooth edges on exposed parts improve
safety by preventing potential
lacerations or skin injuries from APBRs.
In addition, testing APBR products on
articulating beds allows assessment of
openings that could potentially lead to
entrapment when the bed is adjusted
from the flat position to the articulated
position.
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3. Performance Requirements
b. Falls
In addition to the general
requirements, several performance
requirements in ASTM F3186–17 are
intended to address the risk of injury
associated with APBRs. These include
requirements for assembly, structural
integrity, retention system performance,
and fall and entrapment prevention.
Falls were the second most common
hazard pattern in the incident data,
accounting for 25 incidents (8 percent).
Staff found that most falls associated
with APBRs involve the victim falling
against or striking the APBR, but these
incident reports usually have limited
details. Therefore, the APBRs might
have played an incidental role in some
of these cases. If the fall was triggered
by the APBR becoming dislodged, or its
position shifted, then these incidents
potentially may be addressed by the
voluntary standard’s structural integrity
testing and the requirement of a
permanently attached retention system
to maintain the installed product in
position. For example, section 6.2 of
ASTM F3186–17 includes a ‘‘structural
integrity’’ requirement that calls for the
installed APBR to extend at least 4
inches above the top of the thickest
recommended mattress. This minimum
height requirement for APBRs may
address some fall incidents by limiting
the ability of consumers to climb over
these products. However, some fallrelated incidents involved the victim
deliberately climbing over the APBR
and this requirement may not prevent
such consumers from falling over the
bed rail.
a. Misassembly and Misinstallation
Staff identified 284 fatal incidents
related to rail entrapment. This hazard
pattern is the most prevalent among the
incidents, accounting for more than 90
percent of all fatal incidents. Effectively
addressing the entrapment hazard
associated with APBRs depends upon,
among other things, consumers
assembling and installing the product
properly. ASTM F3186–17 includes
performance requirements intended to
improve the likelihood that the APBR
will be assembled and installed
properly. For example:
• Section 6.1 sets forth a requirement
for products to include a retention
system, which maintains the installed
product in position without requiring
readjustment of the components. This
retention system must be permanently
attached to the APBR once it has been
assembled and must not be removable
without the use of a tool.
• Section 6.2 includes structural
integrity requirements that call for the
product to be tested without changing
dimensions.
• Section 6.5 requires that structural
components and retention system
components must not be capable of
being misassembled, which the standard
defines as the APBR being assembled in
a way that appears functional but would
not meet the retention system (section
6.1), structural integrity (6.2),
entrapment (6.3), or openings (6.4)
requirements.
The requirement that retention
systems be permanently attached to the
APBR once it has been assembled, and
removable only with a tool, reduces the
likelihood that consumers will misplace
the retention system, and increases the
likelihood that consumers, including
secondary users, will continue to use
the retention system. The requirement
that structural and retention system
components not be misassembled
reduces the risk of injury or death that
could arise from the consumer omitting
key parts of the APBR (e.g., a center rail)
during assembly, in ways that could
result in entrapment or other hazards.
However, the Commission seeks
comment on whether this sufficiently
reduces the risk, or if other measures,
are needed.
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c. Entrapment Testing
Staff identified entrapment as the
most prevalent hazard pattern among
the incidents. In accordance with the
entrapment test methods specified in
section 8 of the standard, section 6.3 of
ASTM F3186–17 requires products to be
tested to assess the potential for
entrapment in four different zones.
These zones represent four of the seven
sectors identified by the FDA in its 2006
guidance document, Hospital Bed
System Dimensional and Assessment
Guidance to Reduce Entrapment (FDA,
2006), as potential areas of entrapment
in hospital bed systems.12 The FDA’s
guidance is based on recommendations
from the Hospital Bed Safety Workgroup
(HBSW), which was formed in 1999 to
address reports of patient entrapment.
ASTM F3186–17 specifies the FDA
probe to test entrapment zones. The
probe design is based on the
anthropometric dimensions of key body
12 The FDA guidance document is available at:
https://www.fda.gov/regulatory-information/searchfda-guidance-documents/hospital-bed-systemdimensional-and-assessment-guidance-reduceentrapment. (FDA, 2016). Three of the zones
identified in the FDA guidance (Zone 5, Zone 6,
and Zone 7) are not applicable to APBRs, or could
not be tested for entrapment, and therefore, they are
excluded from ASTM F3186–17.
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parts, including the head, neck, and
chest of at-risk adults.
Section 8.4 defines the four
entrapment zones tested under ASTM
F3186–17, which are (1) within the
product; (2) between rail support(s) and
the bed mattress, when applicable,
under the product; (3) between the
product and the mattress; and (4)
between the underside of the end of the
product and the mattress. Entrapment
testing to ASTM F3186–17 is performed
using the anthropometric ‘‘entrapment
test probe,’’ which is the cone and
cylinder tool described in the 2006 FDA
guidance document (section 7.2). In
addition, some entrapment zones
require using a force gauge to test the
force applied on the test probe (section
7.3). Table 6 below, describes the four
entrapment zones, with illustrations
from the 2006 FDA guidance document
of sample entrapments within each of
these zones.
Table 6: ASTM F3186 - 17 Entrapment Zones
Zone 1: Within the Product
Entrapment in any open space within the perimeter of the
APBR
Zone 2: Between Rail Support(s) and the Bed Mattress, When
Applicable, Under the Product
Entrapment under the bottom edge of the APBR, between the
rail supports or next to a single rail support, against the
mattress
Zone 3: Between the Product and the Mattress
Entrapment in the space between the inside surface of the
APBR and the side of the mattress
Zone 4: Between the Underside of the End of the Product and
the Mattress
Entrapment under the lowermost portion of the end of the
APBR, against the mattress
Staff’s review of the rail entrapment
incidents, test requirements, and test
methods showed that most of the
reported entrapment fatalities involved
one of the four zones listed above.
Specifically, staff could determine the
entrapment location of 214 of the 284
fatal incidents, and all but six of these
cases occurred in one of the four zones
of entrapment tested in ASTM F3186–
17, as shown in Table 7 below. Based
on this analysis, it is likely that most of
the 70 incidents for which there was
insufficient information to identify the
location of the entrapment also involved
one of these four zones.
Number of
fatalities
Rail entrapment location
Entrapment testing location
Between APBR and mattress .....................................................
Within APBR itself ......................................................................
Against outside of APBR ............................................................
Between APBR and headboard .................................................
Unknown location .......................................................................
Zones 2, 3, or 4 ..........................................................................
Zone 1 ........................................................................................
None ...........................................................................................
None (Zone 6) ............................................................................
Unknown .....................................................................................
200
8
5
1
70
Total .....................................................................................
.....................................................................................................
284
Staff’s evaluation that rail
entrapments predominantly occur in
Zones 1 through 4 is also consistent
with the FDA’s finding that these four
zones accounted for about 80 percent of
hospital bed rail entrapment events
reported to the FDA. FDA’s
recommended dimensional limits for
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these zones and the anthropometric test
probe, serve as the basis for the
entrapment requirements of ASTM
F3186–17. CPSC’s review indicates that
the performance requirements in the
standard, which are based on identified
entrapment patterns and related
anthropometric data, would effectively
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address the entrapment hazard patterns
related to APBRs with proposed
modifications, as discussed in section V.
of this preamble.
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TABLE 7—RAIL ENTRAPMENT INCIDENT LOCATIONS RELATIVE TO ASTM F3186–17 ENTRAPMENT ZONES
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d. Labeling, Warning, and Instructional
Literature Requirements
Section 9.1 of ASTM F3186–17
specifies that the labeling on the APBR
and its retail packaging must be marked
with the type and size of beds and
mattresses, including the mattress
thickness range for which the APBR is
intended. In addition, the labeling and
retail packaging on the APBR must state
the appropriate distance between an
installed APBR and the headboard or
footboard of the bed. The space between
the APBR and headboard or footboard is
considered Zone 6 under the 2006 FDA
guidance document. ASTM F3186–17
requires the consumer to correctly
install the APBR at the specified
distance from the headboard or
footboard to prevent entrapment. This
hazard is addressed by requiring
labeling on the APBR to state the
appropriate distance between an
installed APBR and the headboard or
footboard of the bed. Section 9.1 also
specifies that all on-product labels must
be permanent.
Section 9.2 establishes requirements
for warning statements that must appear
on the APBR and its retail packaging,
instructions, and digital or print
advertising. The warning statements
must be easy to understand, and any
other labels or written instructions
provided along with the required
statements cannot contradict or confuse
the meaning of the required warnings or
otherwise be misleading.
Section 11 specifies requirements for
instructional literature that must
accompany APBRs. The instructions
provided must be easy to read and
understand; include assembly,
installation, maintenance, cleaning,
operation, and adjustment instructions
and warnings, where applicable;
include drawings or diagrams to provide
a better understanding of set up and
operation of the product; include
drawings that depict all the entrapment
zones; and include all warning
statements specified in section 9.2,
including warnings about product
damage or misalignment.
Although requirements for labeling,
warning, and instructional requirements
are less effective at reducing hazards
than product designs that directly
address known hazards, these
requirements in the standard improve
safety by addressing risks that may not
be eliminated through design.
For the reasons discussed in section
V. of this preamble, the Commission
preliminarily determines that the
voluntary standard is not likely to
eliminate or adequately reduce the
unreasonable risk of injury associated
with entrapments on APBRs.
Accordingly, the Commission is
proposing to adopt the voluntary
standard with specified modifications
necessary to improve safety and
adequately reduce the unreasonable risk
of injury associated with entrapment on
APBRs.
B. Assessment of Compliance to ASTM
F3186–17
Staff conducted two rounds of market
compliance testing to ASTM F3186–17:
the first round in 2018 and 2019, the
second round in 2021. In both rounds,
no APBRs met all requirements of
ASTM F3186–17. All products failed at
least one critical mechanical
requirement, such as retention strap
performance, structural integrity, and
entrapment. As described in Tabs C and
D of the Staff’s NPR briefing package, an
APBR that fails any one mechanical
performance requirement could result in
a fatal entrapment. Furthermore, all
products failed the labeling, warning,
and instructional requirements. This
section discusses market compliance
with ASTM F3186–17.
1. 2018–2019 APBR Market Compliance
Testing
From 2018 through 2019, CPSC’s
Directorate for Laboratory Sciences,
Division of Mechanical Engineering staff
tested 35 randomly selected APBR
models for compliance with ASTM
F3186–17, which became effective in
August 2017. APBRs were purchased in
2018. Staff tested the products to
determine if they conformed to the
general requirements and the
performance requirements of the
standard. Staff also tested conformance
with the labeling, warning, and
instructional literature requirements.
Staff found that none of the 35 sampled
products conformed to the voluntary
standard. Staff assessment showed that
market compliance with the standard
was low when staff purchased the
samples in 2018, after the standard had
become effective. However, due to the
lack of compliant labeling, staff could
not confirm all the manufacture dates
for the products to compare them to the
standard’s effective date. As shown in
Table 8 below, compliance varied by
section of the standard. Overall, 33
APBR models did not meet the
entrapment performance requirements,
and none of the 35 models met the
labeling, warnings, or instructional
literature requirements.
TABLE 8—ASTM F3186–17, 2018 APBR MARKET COMPLIANCE TESTING RESULT SUMMARY
Section
Title
Number of
failed samples
Failure rate
(%)
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(of 35 Total samples tested)
General Requirements:
5.1 ....................................................................
5.2 ....................................................................
5.3 ....................................................................
Performance Requirements:
6.1 ....................................................................
6.2 ....................................................................
6.3 ....................................................................
6.4 ....................................................................
6.5 ....................................................................
Labels and Warnings Requirements:
9.1 ....................................................................
9.2 ....................................................................
Instructional Literature:
11 .....................................................................
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Hazardous Points/Edges ........................................
Jagged Surfaces ....................................................
Articulated Beds .....................................................
0
0
0
0
0
0
Retention Systems .................................................
Structural Integrity ..................................................
Entrapment .............................................................
Openings ................................................................
Misassembled Products .........................................
28
15
33
0
8
80
43
94
0
23
Labeling ..................................................................
Warning Statements ...............................................
35
35
100
100
Instructional Literature ............................................
35
100
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Of the 35 APBR models staff tested,
33 failed at least one of the entrapment
requirements for the four different zones
in and around the APBR. In other
words, 94 percent of samples had at
least one major zone where a body part
could be entrapped. Furthermore, many
samples failed the entrapment
requirements in multiple zones: 14
failed the Zone 1 entrapment
requirement; 27 failed Zone 2; 11 failed
Zone 3; and 6 failed Zone 4.
Staff’s testing also revealed high
failure rates in several other sections,
including the retention system
requirements (28 of 35 samples), and
structural integrity requirements (15 of
35 samples). These types of failures
indicate that the product may not stay
rigidly in place after installation and
will not adequately support the
consumer during normal use conditions,
such as leaning against the product. Not
meeting these requirements thus
significantly increases the likelihood of
entrapment and fall hazards.
Retention system failures occurred
when components were not
permanently attached to the product,
the retention strap permanently
deflected or detached during the freeend pull test,13 or the retention system
did not restrain the product during
entrapment testing. Structural integrity
failures occurred when the APBR did
not extend at least 4 inches over the top
of the thickest recommended mattress,
or when fasteners loosened or detached
during testing, causing the product to
change dimensions.
All 35 models failed the labeling,
warning, and instructional literature
requirements. None of the 35 models
fully met the following requirements:
section 9.1 for retail packaging and
product labels; section 9.2, which
specifies that warning statements must
appear on the product, its retail
package, and its instructions; and
section 11’s requirement to include
instructional literature with required
warning statements. None of the
samples adequately instructed
consumers how to safely install the
APBRs; nor did the samples adequately
inform consumers of the known hazards
related to APBRs. Detailed testing
results are provided in Appendix A of
the Staff’s NPR briefing package.
2. 2021 APBR Market Compliance
Testing
In 2021, CPSC staff conducted a
second round of product testing to
ASTM F3186–17 to determine if the
additional time and outreach efforts by
staff since 2018 was sufficient for
manufacturers to increase their overall
level of compliance to the standard. A
representative total of 17 APBR
products were selected and procured for
testing: these included all eight APBR
models that staff identified as new to
the market since the 2018 analysis, and
67595
nine additional, randomly selected
models from the remaining models
available in the market. The nine
randomly selected models were
products previously identified as
available in the 2018 analysis, and were
included to account for any undisclosed
changes to the models that may have
improved their compliance to the
voluntary standard.
The 2021 testing, like the 2018
analysis, was designed to assess overall
compliance to the voluntary standard,
with a focus on certain sections
including Retention Systems, Structural
Integrity, Entrapment, Openings,
Misassembled Products, Warning
Statements, and Instructional Literature.
All 17 samples failed at least one of
these performance requirements.
Detailed testing results are provided in
Appendix B of the Staff’s NPR briefing
package. Because testing of a sample
was stopped after it failed to meet at
least one performance requirement, the
data collected may not account for all
the potential nonconformities for each
product.
Additionally, none of the 17 models
met the labeling, warnings, and
instructional literature requirements. As
shown in Table 9 below, the failure
modes of this analysis are similar to
those in the 2018 analysis, indicating
little-to-no changes in the market over
this time.
TABLE 9—ASTM F3186–17, 2021 APBR MARKET COMPLIANCE TESTING RESULT SUMMARY
Title
Number of
failed samples
Hazardous Points/Edges ........................................
Jagged Surfaces ....................................................
Articulated Beds .....................................................
0
0
..............................
17
17
0
Retention Systems .................................................
Structural Integrity ..................................................
Entrapment .............................................................
Openings ................................................................
Misassembled Products .........................................
13
7
14
..............................
1
17
7
16
0
1
Labeling ..................................................................
Warning Statements ...............................................
17
17
17
17
Instructional Literature ............................................
17
17
Section
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General Requirements:
5.1 ....................................................................
5.2 ....................................................................
5.3 ....................................................................
Performance Requirements:
6.1 ....................................................................
6.2 ....................................................................
6.3 ....................................................................
6.4 ....................................................................
6.5 ....................................................................
Labels and Warnings Requirements:
9.1 ....................................................................
9.2 ....................................................................
Instructional Literature:
11 .....................................................................
4. Section 15 Compliance Actions 2021–
2022
CPSC has issued five public notices
regarding APBRs that did not comply
with ASTM F3186–17. In April 2021,
13 The proposed rule defines ‘‘free-end’’ as the
location on the retention system that is designed to
produce a counter force; it may be a single distinct
point or a location on a loop.
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Number of
samples tested
CPSC warned consumers to stop using
three models of APBRs manufactured by
Bed Handles, Inc., because the products
pose an entrapment hazard.14 Bed
Handles, Inc., manufactured
approximately 193,000 units of the bed
rails, and CPSC is aware of four
entrapment deaths associated with
them.
In December 2021, CPSC announced
voluntary recalls of APBRs
manufactured by three firms, due to the
14 Press Release (PR) #21–122, https://
www.cpsc.gov/Newsroom/News-Releases/2021/
CPSC-Warns-Consumers-to-Stop-Use-of-ThreeModels-of-Adult-Portable-Bed-Rails-Manufactured-
by-Bed-Handles-Inc-Due-to-Entrapment-AsphyxiaHazard.
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entrapment hazard and risk of death by
asphyxia posed by their products:
• Drive DeVilbiss Healthcare (496,100
units, 2 deaths); 15
• Compass Health Brands (104,900
units, 3 deaths); and 16
• Essential Medical Supply, Inc.
(272,000 units, 1 death).17
In June 2022, CPSC warned
consumers to stop using 10 models of
APBRs manufactured and sold by
Mobility Transfer Systems, Inc. from
1992 to 2021, and by Metal Tubing
USA, Inc. in 2021 and 2022. Three
entrapment deaths involving one model
have occurred.18 Neither firm agreed to
conduct a recall. Approximately
285,000 units were manufactured.
5. APBR Market Compliance Testing
Summary
As discussed in section V. of this
preamble, the Commission preliminarily
determines that, without additional
modifications, the voluntary standard is
insufficient to eliminate or adequately
reduce the unreasonable risk of injury of
entrapments on APBRs. Moreover,
based on staff’s test results showing that
there is no market compliance with the
voluntary standard, the Commission
preliminarily determines that
substantial compliance to a voluntary
adult portable bed rail safety standard is
unlikely. Accordingly, the Commission
proposes to incorporate by reference,
ASTM F3186–17 with modifications, to
require APBR manufacturers to comply
with the mandatory standard and
thereby improve safety.
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V. Proposed Requirements
The Commission preliminarily
determines that ASTM F3186–17, with
modifications to improve safety, would
15 PR #22–025, https://www.cpsc.gov/Recalls/
2022/Drive-DeVilbiss-Healthcare-Recalls-AdultPortable-Bed-Rails-After-Two-Deaths-Entrapmentand-Asphyxiation-Hazards.
16 PR #22–040, https://www.cpsc.gov/Recalls/
2022/Compass-Health-Brands-Recalls-Carex-AdultPortable-Bed-Rails-After-Three-Deaths-Entrapmentand-Asphyxiation-Hazards.
17 PR #22–039, https://www.cpsc.gov/Recalls/
2022/Essential-Medical-Supply-Recalls-AdultPortable-Bed-Rails-Due-to-Entrapment-andAsphyxia-Hazard-One-Death-Reported.
18 PR #22–148, https://www.cpsc.gov/Newsroom/
News-Releases/2022/CPSC-Urges-Consumers-toImmediately-Stop-Use-of-Mobility-TransferSystems-Adult-Portable-Bed-Rails-Due-toEntrapment-and-Asphyxia-Hazard-Three-DeathsReported.
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likely address all known product hazard
modes associated with APBRs, and
particularly entrapment. These
modifications are as follows:
• Provide additional definitions for
product ‘‘assembly’’ and ‘‘installation’’
to ensure their consistent and
differentiated use throughout the
document;
• Include recommendations for
manufacturers to take into account the
range of mattress thicknesses to ensure
safe use of the product by the consumer
and provide testers with additional
guidance for selecting the mattress
thickness during the test setup;
• Address inconsistencies with stated
dimensions to ensure consistent
dimensional tolerances;
• Provide additional clarity for Zone
1 and 2 test setup and methods;
• Provide additional guidance for
identifying potential Zone 2 openings;
• Update the requirements for Zone 3
testing for consistency; and
• Make grammatical and editorial
corrections.19
components after purchase, and prior to
installing on the bed.
• Section 3.1.9: Initial Installation,
the first installation of the product onto
a bed or mattress.
• Section 3.1.10: Installation
Component, component(s) of the bed
rail that is/are specifically designed to
attach the bed rail to the bed and
typically located under the mattress
when in the manufacturer’s
recommended use position.
These proposed definitions are
intended to differentiate between
‘‘assembly’’ and ‘‘installation’’ so
manufacturers can ensure products meet
the requirements of sections 6.1.3 and
9.2.7, as discussed below. Although
‘‘installation component’’ is used
throughout the voluntary standard, it
was not explained. The new proposed
definition helps clarify the location of
warnings from section 9.2.7.
A. Description of Proposed § 1270.1—
Scope, Application, and Effective Date
Proposed § 1270.1 provides that new
part 1270 establishes a consumer
product safety standard for APBRs
manufactured after 30 days after
publication of the final rule in the
Federal Register.
The Commission proposes to revise
sections 6.1.3 and 9.2.7 with the
definitions provided in proposed
sections 3.1.8, 3.1.9 and 3.1.10 as
follows:
• Section 6.1.3: Revise ‘‘Permanently
attached retention system components
shall not be able to be removed without
the use of a tool after initial
installation’’ by changing ‘‘initial
installation’’ to ‘‘initial assembly.’’
Staff’s review shows that making the
retention system permanent during
product assembly ensures that retention
system integrity is maintained, even if
the product is reinstalled after initial
assembly. Retention systems are a
critical component for reducing known
product hazards. Removable retention
systems are known to lead to
entrapment hazards. The additional
definitions make clear that retention
system should remain attached to the
product and should not be
compromised after initial assembly and
between uninstallation, and
reinstallation of the product.
• Section 9.2.7: Revise ‘‘At least one
conspicuous component of the product
must be labeled with the following
entrapment warning’’ by changing
‘‘conspicuous component’’ to
‘‘installation component.’’
B. Description of Proposed § 1270.2—
Requirements for Adult Portable Bed
Rails
Proposed § 1270.2 sets forth the
requirements for APBRs that are
required in addition to those required
by ASTM F3186–17. Section 1270.2(a)
would require each APBR to comply
with all applicable provisions of ASTM
F3186–17 with the following changes as
set forth in § 1270(b):
1. Propose New Clarifying Definitions
on ‘‘Assembly’’, ‘‘Installation’’ and
‘‘Component’’(Sections 3.18, 3.1.9,
3.1.10)
The Commission proposes to add the
following new definitions to ASTM
F3186–17.
• Section 3.1.8: Initial Assembly, the
first assembly of the product
19 Tab F of Staff’s NPR briefing package provides
a redline version in sequential order as the sections
appear in ASTM F3186–17.
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2. Propose Clarifications to Sections
6.1.3 and 9.2.7
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67597
AW ARNING- ENTRAPMENT HAZARD
NEVER use product without properly securing it to bed. Incorrect installation
can allow product to move away from mattress, bed frame and/or head or foot
boards, which can lead to entrapment and death.
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3. Propose Clarifications to Sections
6.5.1 and 6.5.2
The Commission proposes to clarify
the following sections of ASTM F3186–
17:
• § 6.5.1: Revise ‘‘Any structural
components and retention system
components of a product covered by
this specification that require consumer
assembly shall not be able to be
misassembled when evaluated to 6.5.2’’
to ‘‘Any structural components and
retention system components of a
product covered by this specification
that require consumer assembly or
adjustment, or components that may be
removed by the consumer without the
use of a tool, shall not be able to be
misassembled when evaluated to 6.5.2.’’
This revision clarifies that
disassembly with the use of a tool is not
considered as ‘‘misassembly’’ under
section 6.5.
Section 6.5.2: Revise ‘‘Determining
Misassembled Product: A product
covered by this specification shall be
considered misasssembled if it appears
to be functional under any condition
and it does not meet the requirements
of 6.1–6.4.’’
This editorial change corrects the
misspelling of ‘‘misasssembled’’ to
‘‘misassembled.’’
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4. Propose New Sections to Address
Mattress Variability (Section 6.2.1.1,
Section 7.1.3)
Staff’s review shows that mattress
thickness is a known variable that may
cause some APBR product designs to
have hazardous entrapment zones.
Accordingly, to improve the safety of
APBRs, the ASTM F3186–17
requirements should provide additional
guidance on what thickness of mattress
to use for testing APBR products. The
following proposed new sections
address this issue:
• Section 6.2.1.1: If the manufacturer
does not recommend a specific
applicable range of mattress heights or
thicknesses, the test personnel shall
choose a mattress that provides the most
severe condition per test requirement. If
the product has adjustable settings, and
the manufacturer does not recommend
orienting or adjusting features on the
product in a specific manner, the testers
shall adjust the product to the most
severe condition per test requirement.
Defining a range of recommended
mattress thicknesses provides
consumers with necessary information
for safe use of the product. If no
mattress thickness is recommended,
consumers may incorrectly assume safe
use with any mattress thickness.
Similarly, products may come with
many types of adjustable settings. If
appropriate setting recommendations
are not provided, consumers may
incorrectly assume all settings are safe.
This requirement does not supersede
misassembly requirements in section 6.5
but is proposed to be applied in
addition to those requirements.
• Section 7.1.3: Mattress thickness
ranges used for testing may be up to 1.5
in (38 mm) larger or smaller than the
range specified by the manufacturer. If
the manufacturer does not recommend a
particular range of mattress heights, the
testers shall choose a mattress that
provides the most severe condition per
test requirement. NOTE *: Proposed
Mattress Type Clarification: The
technology and consumer preferences
for bedding are highly variable and
continuously changing. Therefore, they
cannot be reasonably accounted for
within this standard. Test facilities and
personnel should consider current
bedding trends and all types of
mattresses that may foreseeably be used
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Sfmt 4702
with the product when making a test
mattress selection.
Because mattress types are constantly
changing, the proposed language in
sections 6.2.1.1 and 7.1.3 informs
manufacturers and testers to be aware of
the types and variability of mattresses
consumers may be using with these
products and test accordingly.
Consumers cannot be expected to be
able to consistently measure mattress
thickness, nor to purchase a new
mattress for proper compatibility with a
bed rail. Additionally, consumers are
likely to follow nominal thickness
descriptors of their mattresses which
may vary from actual specifications.
This additional range proposed for
testing in new proposed section 7.1.3
may be up to 1.5 in (38 mm) larger or
smaller than the range specified by the
manufacturer, will increase safety by
accounting for foreseeable reasonable
differences between nominal and actual
mattress thicknesses.
5. Propose Revisions to Entrapment Test
Probe (Section 7.2) To Update
References
• Section 7.2: Entrapment Test
Probe—This section is revised to update
references. Currently, ASTM F3186–17
provides that: The test probe shall be as
described in the FDA Guidance
Document, ‘‘Hospital Bed System
Dimensional and Assessment Guidance
to Reduce Entrapment,’’ which can be
found at: http://www.fda.gov/Medical
DeviceRegulationandGuidance/
GuidanceDocuments/ucm072662. The
test probe can be independently
manufactured or it can be purchased
from NST Sales & Customer Service
Office, 5154 Enterprise Blvd., Toledo,
Ohio 43612, 800–678–7072, www.nstusa.com. video illustrating use of the
test probe is available at the NST
website (free registration required).
To update outdated references, this
section is proposed to be changed to
state that the FDA guidance may be
found at www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/hospital-bed-systemdimensional-and-assessment-guidancereduce-entrapment. The test probe can
be independently manufactured per the
dimensional constraints in the guidance
document or purchased from Bionix
Development Corporation, 5154
Enterprise Blvd., Toledo, OH 43612,
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Staff’s review demonstrates that this
warning is intended to draw attention to
the installation component and to
encourage its use. The installation
component is commonly located under
the mattress during use, and therefore,
the warning would not be
‘‘conspicuous’’ when in the
manufacturer’s recommended use
position. Requiring the warning to be on
a ‘‘conspicuous component’’ most likely
would not permit the warning to be
placed on an installation component.
The proposed language would instead
draw attention to the installation
component. Furthermore, the warning
required by section 9.2.6, which also
discusses entrapment hazards and
keeping the product tight against the
mattress, is required to be placed on an
installation component rather than on a
conspicuous component.
Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Proposed Rules
800–551–7096, https://bionix.com.
Videos illustrating use of the test probe
are available at www.youtube.com/c/
BionixLLC/search.’’
6. Propose Revisions to Performance
Requirements for Zone 3 Entrapment
(Sections 6.3.3, 8.4.5.4, and 6.4.1)
The Commission is proposing
revisions to test for Zone 3 entrapment
hazards
• Section 6.3.3: Zone 3—Revise ‘‘The
highest point on the cylinder of the test
probe (see 7.2) shall not pass completely
below the horizontal uncompressed
Highest Point of
Uncompressed
plane of the mattress when tested
according to 8.4.5.’’ Add at the end of
the sentence ‘‘. . .when tested in
accordance with section 8.4.5, the
horizontal centerline on the face of the
4.7 in (120 mm) end of the test probe
(see 7.2) shall be above the highest point
of the uncompressed mattress.’’
• Section 8.4.5.4: Revise ‘‘Turn the
cone until the centerline on the face of
the 4.7 in (119.38 mm) end is horizontal
and let the cone sink into the space by
its own weight. (1) If the line on the face
of the 4.7 in (120 mm) end of the cone
Centerline
Highest Point of
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Figure 4a: Zone 3 Pass Criteria
(Centerline above highest point of uncompressed
mattress)
CPSC staff’s review showed that the
Zone 3 entrapment performance
requirement in section 6.3.3 is
redundant due to the failure criteria
described in the associated test method,
section 8.4.5.4. To ensure consistency,
proposed revisions to these sections
more accurately describe the test
method for the highest level of safety
and are also more consistent with the
FDA guidance document referenced in
the standard. In addition, the Figures 4a
and 4b are proposed to assist testers in
visualizing the test criteria.
• Section 6.4.1 Revise the
measurements in ‘‘Holes or slots that
extend entirely through a wall section of
any rigid material less than 1⁄4 in (6.35
mm) thick and admit a 5⁄8 in (15.9 mm)
diameter rod shall also admit a 1 in
(25.4 mm) diameter rod. Holes or slots
that are between 8 mm and 25 mm and
have a wall thickness less than 1⁄4 in
(6.35 mm) but are limited in depth to 1⁄4
in (6.35 mm) maximum by another rigid
surface shall be permissible (see Fig. 2)’’
to the following: ‘‘Holes or slots that
extend entirely through a wall section of
any rigid material less than 0.375 in
(9.53 mm) thick and admit a 0.210 in
(5.33 mm) diameter rod shall also admit
a 0.375 in (9.53 mm) diameter rod.
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7. Revise Entrapment Testing Probe Pull
Force Application for Entrapment Zones
1 and 2
To make the current language and test
method in ASTM F816–17 section 8.4.4
for Zone 2 entrapment testing (Between
the Product Support(s) and the Bed
Mattress, When Applicable, Under the
Product) clearer and more repeatable,
the proposed rule contains the following
changes under section 8.4.4.
• Section 8.4. NOTE 1: Revise ‘‘The
tests described in this section are
identical to those described in the
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Fmt 4702
Centerline
Figure 4b: Zone 3 Fail Criteria
(Centerline below highest point of uncompressed
mattress)
Holes or slots that are between 0.210 in
(5.33 mm) and 0.375 in (9.53 mm) and
have a wall thickness less than 0.375 in
(9.53 mm) but are limited in depth to
0.375 in (9.53 mm) maximum by
another rigid surface shall be
permissible (see Fig. 2).’’
Staff’s review showed that the
measurement references in 6.4.1 were
not accurate or consistent throughout
the section, or the referenced Figure 2.
The proposed change to this section
fixes those issues and harmonizes the
requirements with other established
ASTM standards that have similar
requirements such as ASTM F2085
(Children’s Portable Bed Rails), codified
under 16 CFR part 1224.
PO 00000
is above the surface of the mattress
highest point of the uncompressed
mattress, as shown in Figure 4a, the
space passes the test. (2) If the line on
the face of the 4.7 in (120 mm) end of
the cone is at or below the surface of the
mattress, the space fails the test.’’
Instead of the ‘‘below the surface of the
mattress’’ insert ‘‘below the highest
point of the uncompressed mattress, as
shown in Figure 4b.’’
• Section 8.4.5.4. Add the following
proposed figures (Figure 4a and Figure
4b) for reference for Zone 3 test:
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referenced FDA Guidance Document
and in the NSA video’’ to ‘‘The tests
described in this section are similar to
those described in the referenced FDA
Guidance Document.’’
Although the FDA guidance
document is the source of the
entrapment test methodologies, there
are several differences in the proposed
standard and the FDA guidance
document. In addition, the NSA video is
not available.
• Section 8.4.3.4: Revise ‘‘If the test
probe does not pull through freely
attach the force gauge and exert a 22.5
lbf (100 N) pulling force to the 2.4 in (60
mm) cylindrical end of the entrapment
test tool perpendicular to the plane of
the opening in both directions. If the 4.7
in (120 mm) end of the cone does not
enter any of the openings, this space
passes the test. If the 4.7 in (120 mm)
end of the test probe cone does enter
and pass through any of the openings,
this space fails the test’’ to ‘‘If the test
probe does not pull through freely
attach the force gauge and exert a 22.5
lbf (100 N) pulling force along the axis
of the cone, perpendicular to the 2.4 in
(60 mm) cylindrical end of the
entrapment test tool. If the 4.7 in (120
mm) end of the cone does not enter any
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• Section 8.4.4.4: Revise ‘‘Using the
force gauge, exert a 22.5 lbf (100 N)
pulling force to the 2.4 in (60 mm)
cylindrical end of cone in both
directions perpendicular to the rail’’ to
‘‘If the test probe does not pull through
freely, use the force gauge to exert a 22.5
lbf (100 N) pulling force along the axis
of the cone, perpendicular to the 2.4 in
(60 mm) cylindrical end of cone.’’
The intent of this test is to determine
if both the 2.4 in and 4.7 in portions of
the test probe cone can enter or pass
through the Zone 2 opening under the
required force. This would mean that a
body part can be entrapped, and a
hazard is present. Applying the pull
force perpendicular to the 2.4 in
cylindrical end of the cone represents
these known hazards better when
compared to a pull force applied
perpendicular to the face of the rail, and
also reduces ambiguity.
In addition, to take in account bed
rails that have significant overhang, the
NPR proposes to add new section
8.4.4.5.
• Section 8.4.4.5: If a horizontal
section of the rail greater than 4.7 in
(120 mm) exists along the bottom of the
rail, that section must also meet the
Zone 2 requirements.
Bed rails that have significant
overhanging elements that would allow
the passage of the head in a manner
consistent with identified Zone 2
entrapment hazards were not
considered during the development of
the APBR testing procedure, but the
overhang could potentially result in a
similar entrapment. Thus, the
requirements and test methods for these
types of openings should be consistent
with the Zone 2 requirements as
reflected in the proposed language.
8. Propose New Note To Clarify
Retention Test
Section 8.6.3 of ASTM F3186–17
currently requires that ‘‘a 50 lbf force
(222.5 N) force to be applied to the free
end of the retention system in the
horizontal direction,’’ without
adequately defining the term ‘‘free end’’.
By adding a note to the end of section
8.6.3., to explain the location of the
‘‘free end’’ will clarify the test method
for testers and make it more repeatable.
Accordingly, the Commission proposes
to add the following note:
• Section 8.6.3 NOTE ***: The ‘‘free
end’’ is defined as the location on the
retention system that is designed to
produce a counter force; it may be a
single distinct point or a location on a
loop.
9. Propose Clarifications to Labels and
Warning Requirements.
• Section 9.1.1.3: Revise ‘‘That the
product is to be used only with the type
and size of mattress and bed, including
the range of thickness of mattresses
specified by the manufacturer of the
product. If beds with head or footboards
are allowed, the distance between the
head or footboard and the placement of
the product shall be indicated to be
either <2.4 in (60 mm) or >12.5 in (318
mm)’’ to remove ‘‘either <2.4 in (60 mm)
or’’ from the last sentence.
This proposed change addresses an
inconsistency between section 9.1.1.3,
which states that products may be
installed <2.4 in or >12.5 in away from
head or footboards, and section 9.2.6,
which states that products must be
installed at least 12.5 in from
headboards or footboards.
• Section 9.2.5: Revise the warning
statement: Each product’s retail package
and instructions shall include the
following warning statements:
•WARNING
ENTRAPMENT, STRANGULATION, SUFFOCATION AND FALL HAZARDS
Gaps in and around this product can entrap and kill. People with Alzheimer's disease or
dementia, or those who are sedated, confused, or frail, and are at increased risk of
entrapment and strangulation. People attempting to climb over this product are at
increased risk of injury or death from falls. Always make sure this product is properly
secured to bed. If product can move away from bed or mattress, it can lead to entrapment
and death.
to delete ", and" after "frail".
This proposed change is a
grammatical edit and brings the warning
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language into alignment with similar
language used in section 9.2.6.
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• Section 11.1.1.3: Revise ‘‘In
addition to contacting the manufacturer
directly, consumers should report
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of the openings, this space passes the
test. If the 4.7 in (120 mm) end of the
test probe cone does enter any of the
openings, this space fails the test.’’
As explained by CPSC staff, the intent
of this test is to determine if both the 2.4
in and 4.7 in portions of the test probe
cone can enter or pass through any Zone
1 opening under the required force. This
would mean that a body part can be
entrapped, and a hazard is present.
Furthermore, applying the force
perpendicular to the opening may have
multiple interpretations and may not
always emulate the known hazard of
head or limb entrapment. Applying the
pull force perpendicular to the 2.4 in
cylindrical end of the cone better
represents these known hazards when
compared to a pull force applied
perpendicular to the face of the rail.
• Section 8.4.4.3: Revise ‘‘Insert the
2.4 in (60 mm) end of the cone
perpendicular to the opening from the
longitudinal centerline of the mattress’’
to ‘‘Insert the 2.4 in (60 mm) end of the
cone into the opening.’’ Slide the cone
into the opening until it is in full
contact with the product. The mattress
shall only be compressed by the weight
of the cone.
The intent of this requirement is to
address entrapment hazards associated
with bed rails and head entrapment in
Zone 2 by ensuring that the test probe
cannot pass through any openings in the
entrapment zone. This criterion is based
on the FDA guidance document, which
includes a dimension of 120 mm (4.75
in), encompassing the 5th percentile
female head breadth. This dimension is
represented by the 4.7 in portion of the
test probe, and it should be applied in
any orientation in which the head may
be entrapped. The removed language
may have led test personnel to
unnecessarily restrict orientations to
which the probe is applied.
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problems to the CPSC at is website
SaferProducts.gov or call 1–800–638–
2772, or to the FDA at 1–800–332–
1088’’ to change ‘‘is’’ to ‘‘its.’’
This proposed change is a
grammatical edit.
C. Description of Proposed § 1270.3—
Prohibited Stockpiling
The CPSC is proposing an antistockpiling provision to prevent firms
from manufacturing large quantities of
non-compliant APBRs before the rule
takes effect and seeks comment on this
provision. This section would make it a
prohibited act for manufacturers and
importers to manufacture or import
APBRs that do not comply with the
requirements of this part in any 1-month
period between the date of publication
of the final rule and the effective date
of the final rule at a rate that is greater
than 105 percent of the rate at which
they manufactured or imported APBRs
during the base period for the
manufacturer or importer. The proposed
base period for APBRs would be the
calendar month with the median
manufacturing or import volume within
the last 13 months immediately
preceding the month of promulgation of
a final rule.
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D. Proposed Findings—§ 1270.4
The findings required by section 9 of
the CPSA are discussed throughout this
preamble and set forth in § 1270.4 of the
proposed rule.
VI. Preliminary Regulatory Analysis
Pursuant to section 9(c) of the
Consumer Product Safety Act,
publication of a proposed rule must
include a preliminary regulatory
analysis containing:
• A preliminary description of the
potential benefits and potential costs of
the proposed rule, including any
benefits or costs that cannot be
quantified in monetary terms, and an
identification of those likely to receive
the benefits and bear the costs.
• A discussion of why a relevant
voluntary safety standard would not
eliminate or adequately reduce the risk
of injury addressed by the proposed
rule.
• A description of any reasonable
alternatives to the proposed rule,
together with a summary description of
their potential costs and benefits and
why such alternatives should not be
published as a proposed rule.
A. Preliminary Description of Potential
Benefits and Costs of the Rule
CPSC’s preliminary assessment of the
potential benefits and costs show that
the annualized present value of the
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potential societal costs of the proposed
rule is $298.11 million. If 92 percent of
deaths caused by entrapment are
addressed by the proposed rule, there
are potential annual benefits of $266.99
million. CPSC also assessed lower
efficacy rates of the proposed rule
which showed the quantifiable benefits
of the proposed rule in the range of
$66.75 million (assuming a 25% efficacy
rate) to $200.24 million per year
(assuming a 75% efficacy rate). The
costs associated with the proposed
requirements to prevent the hazards
associated with APBRs are expected to
be $2.01 million per year. On a per
product basis, the benefits of the
proposed rule are estimated between
$110.59 per APBR (25%) and $331.78
per APBR (75%), and the costs are
estimated at $3.34 per APBR. All these
amounts are in 2021 dollars using a
discount rate of 3 percent. Staff’s
analysis is based is based on incident
reports for entrapments, only. Although
APBRs may have been involved in other
deaths or injuries, such as falls, those
incidents are not considered in the
benefit cost analysis because there are
limited details involving such incidents,
and it is unclear whether these
incidents would be prevented by the
proposed rule.
1. Benefits of the Proposed Rule
The potential benefits and costs of the
proposed rule are discussed in Tab G of
the Staff’s NPR briefing package. The
most common hazard pattern among all
reported incidents is rail entrapment,
accounting for more than 90 percent
(284 of 310) of the fatal incidents. For
the preliminary regulatory analysis, staff
chose the period of 2010 through 2019
to base its rates of fatalities per product
because it was the most recent 10-year
window where all or nearly all
incidents have been reported. Staff
identified 158 deaths from entrapment
that occurred from 2010 through 2019.
This number accounts for 92 percent of
observed death incidents; the remaining
8 percent were caused by underlying
incidents that may or may not be
prevented by the proposed rule. To
forecast entrapment deaths into the
future, staff used death rates per million
APBRs in conjunction with its forecast
of APBRs in use throughout the study
period. Staff assumed deaths would stay
the same as the average rates observed
between 2010 to 2019: 31.9 deaths per
million APBRs. Staff forecasted APBRs
in use using the population breakdown
by age of APBR users, adjusted for
population demographics and the
growth of home healthcare spending.
To estimate the societal costs of
entrapment deaths, staff applied the
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value of statistical life (VSL). VSL is an
estimate used in benefit-cost analysis to
place a value on reductions in the
likelihood of premature deaths. The
VSL does not place a value on
individual lives, but rather, it represents
an extrapolated estimate, based on the
rate at which individuals trade money
for small changes in mortality risk. This
is a ‘‘willingness to pay’’ methodology
that attempts to measure how much
individuals are willing to pay for a
small reduction in their own mortality
risks, or how much additional
compensation they would require to
accept slightly higher mortality risks.
For this analysis, staff applied estimates
of the VSL developed by the U.S.
Environmental Protection Agency
(EPA). The EPA estimate of the VSL,
when adjusted for inflation, is $10.5
million in 2021 dollars. Staff multiplied
the VSL by the number of forecasted
deaths throughout the study period to
calculate societal costs of deaths from
entrapment in the absence of the
proposed rule.
CPSC staff assumes that the number of
firms and APBR models in use will tend
to be stable in future years around the
values in 2022: 12 firms and 65 models.
The market for APBRs is expected to
grow at an average rate of 2.01 percent
between 2024 and 2053 as a result of an
aging U.S. population. Assuming the
rates of incidents per million APBRs
stays constant, an industry of this size
would result in an average of 32 deaths
from entrapment per year. At a value of
a statistical life (VSL) of $10.5 million
(2021 dollars), the annualized present
value of the potential costs of the
proposed rule is $298.11 million.
Staff did not include injuries in its
benefit-cost assessment because for
many incidents involving injuries, there
is not sufficient information to
determine whether they would be
prevented by the proposed rule.
However, staff has quantified and
monetized the injuries in a sensitivity
analysis as a potential upper limit to
assess the benefits of this proposed rule.
The requirements of the proposed rule
are expected to address 92 percent of
deaths caused by entrapment. However,
staff also assessed potential benefits
under three scenarios derived from this
baseline efficacy, estimating benefits at:
75 percent, 50 percent, and 25 percent
of their potential value.
At these rates under varying
conservative assumptions (i.e., likely to
underestimate the benefits of the rule),
CPSC staff estimates the annualized
benefits of the proposed rule to be
$200.24 million, $133.49 million, and
$66.75 million, respectively. As
discussed below, staff estimates
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annualized costs associated with the
proposed requirements to prevent APBR
hazards to be approximately $2 million.
This results in net quantifiable benefits
of $198.23 million, $131.48 million, and
$64.74 million on an annualized basis
under these various scenarios that
assume reduced benefits. Table 10
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shows the annualized net benefits under
the scenarios.
TABLE 10—NET BENEFITS OF PROPOSED RULE
Portion of benefits achieved over the baseline
efficacy rate of redesigned APBRs
Annualized net benefits
($M, discounted at 3%)
75%
Benefits ........................................................................................................................................
Costs ............................................................................................................................................
Net Benefits (Benefits-Costs) ......................................................................................................
B/C Ratio .....................................................................................................................................
Table 11 compares the benefits and
costs on a per-unit basis, to add a
marginal value perspective.20 These
50%
$200.24
2.01
198.23
99.45
$133.49
2.01
131.48
66.30
25%
$66.75
2.01
64.73
33.15
metrics again show the proposed rule’s
benefits well exceed costs at each
scenario.
TABLE 11—SHOWS THE PER-APBR NET BENEFITS OF THE PROPOSED RULE
Portion of benefits achieved over the baseline
efficacy rate of redesigned APBRs
Per unit net benefits
($, discounted at 3%)
75%
Benefits ........................................................................................................................................
Costs ............................................................................................................................................
Net Benefits (Benefits-Costs) ......................................................................................................
B/C Ratio .....................................................................................................................................
2. Costs of the Proposed Rule
Staff’s regulatory assessment of the
costs of the proposed rule assumed that
100 percent of manufacturers will fully
redesign their APBR models to comply
with ASTM F3186–17, with
modifications. Like the benefits
estimation, the time span of the cost
analysis covers a 30-year period that
starts in 2024, which is the expected
year of implementation of the rule. This
cost analysis presents all cost estimates
in 2021 dollars. This cost analysis also
discounts costs in the future and uses a
3 percent discount rate to estimate their
present value.21
The cost of implementing an APBR fix
to address entrapment hazards includes
the costs manufacturers incur to
redesign existing models and produce
new designs to comply with ASTM
F3186–17, as well as any additional cost
of producing the APBR that is
associated with its redesign.
Manufacturers incur design costs that
include redesigning existing APBR
models, and designing APBR models in
the future, to comply with the ASTM
F3186 as modified. Manufacturers
would likely incur expenditures in
design labor, design production, design
validation, and compliance testing.
Staff’s review indicates that once
existing models have been redesigned
with a working solution, new models
can adapt the solution at a minimal cost.
Manufacturers can transfer some, or
all, of the increased production cost to
consumers through price increases. In
the first year, staff expects producer
manufacturing costs to increase by $5.40
per APBR, of which $4.00 per APBR is
50%
$331.78
3.34
328.45
99.45
$221.19
3.34
217.85
66.30
25%
$110.59
3.34
107.26
33.15
expected to be passed on to the
consumer in the form of higher prices.
At the margins, some producers may
exit the market because their increased
marginal costs now exceed the increase
in market price. Likewise, a fraction of
consumers would now probably be
excluded from the market because the
increased market price exceeds their
personal price threshold for purchasing
an APBR. Deadweight loss is the
measure of the losses faced by marginal
producers and consumers who are
forced out of the market due to the new
requirements of the proposed rule. For
this analysis, staff estimated deadweight
loss for each year the proposed rule is
expected to have an impact on marginal
cost and market price. Table 12
summarizes the cost of the proposed
rule:
TABLE 12—TOTAL COST OF THE PROPOSED RULE
Total cost
($M)
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Costs of proposed rule
Cost of Redesigning Existing Models ......................................................................................................................
Cost of Production of Redesigned APBRs ..............................................................................................................
20 Average undiscounted benefits are calculated
by summing the benefits from the proposed rule
over the 2024–2053 study period and dividing by
the number of APBRs produced during the same
period. Average undiscounted costs are similarly
calculated. Present Values are calculated by
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determining the benefits and costs of the proposed
rule in the year in which they were incurred and
discounting those values by 3 percent for each
future year. The present values are summed over
the 30-year study period and divided by the number
of APBRs produced during this same period.
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$2.75
60.43
Present value
($M)
$2.59
35.65
21 Discounting future estimates to the present
allows staff not only to consider the time value of
money, but also the opportunity cost of the
investment, which is, the value of the best
alternative use of funds.
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TABLE 12—TOTAL COST OF THE PROPOSED RULE—Continued
Total cost
($M)
Costs of proposed rule
Present value
($M)
Deadweight Loss .....................................................................................................................................................
2.07
1.23
Total Costs .......................................................................................................................................................
65.24
39.46
3. Sensitivity Analysis
A major source of uncertainty is the
omission of nonfatal entrapment
injuries in the benefits assessment. This
may result in a significant underestimation of the benefits of the
proposed rule. In its sensitivity analysis,
staff included the benefits of averting all
nonfatal injuries reported in NEISS,
despite the uncertainty of whether these
incidents would be in-scope of this
proposed rule. These estimates serve as
the theoretical upper bound of benefits
from the proposed rule.
Staff used NEISS incidents and the
Injury Cost Model (ICM) to extrapolate
and generate national estimates for
injuries from entrapment treated in EDs
and other settings. The ICM calculated
that there were 125,121 nonfatal injuries
from entrapment in the United States
from 2010 to 2019. Of this total, 79,563
were treated in an outpatient setting
(e.g., doctor’s office, or clinic), 39,149
resulted in ED treatment, and 6,409
resulted in hospital admissions. Over 30
years, staff estimates the societal costs
from injuries associated with
entrapments, annualized and
discounted at 3 percent, to be $195.52
million for doctor’s office/clinic,
$179.49 million for ED, and $289.64
million for hospital admissions.
To forecast injuries from entrapment
into the future, staff used injury rates
per million APBRs in conjunction its
forecast of APBRs in use throughout the
study period. Staff assumed injuries
would stay the same as the average rates
observed between 2010 to 2019: 1,293.6
hospital admissions per million APBRs
in use; 7,902.2 ED admissions per
million APBRs in use; and 16,059.7
doctor/clinic visits per million APBRs
in use. Staff forecasted APBRs in use
based on the population breakdown by
age of APBR users, adjusted for
population demographics and the
growth of home healthcare spending.
Staff estimated the societal costs of
nonfatal injuries using the ICM. The
ICM estimates that the costs (in 2021
dollars) associated with nonfatal
entrapment injuries using the quality
adjusted life years are: $15,270 for
injuries treated at the doctor’s office/
clinic; $28,849 for injuries treated in the
ED; and $280,832 for injuries that result
in hospital admission.
Table 13 below displays metrics for
the benefits and costs of the proposed
rule. The table displays net benefits
(difference between benefits and costs)
and the benefit-cost ratio (benefits
divided by costs) to assess the costbenefit relationship. The table displays
these metrics using annualized benefits
for the three scenarios: 75 percent, 50
percent, and 25 percent. These metrics
show the proposed rule’s benefits well
exceed costs in each scenario.
Table 13 displays metrics for benefits,
with nonfatal injuries included, and
costs of the proposed rule.
TABLE 13—NET BENEFITS OF PROPOSED RULE
Portion of benefits achieved over the baseline
efficacy rate of redesigned APBRs
Annualized net benefits
($M, discounted at 3%)
75%
Benefits ........................................................................................................................................
Costs ............................................................................................................................................
Net Benefits (Benefits-Costs) ......................................................................................................
B/C Ratio .....................................................................................................................................
50%
$698.73
2.01
696.72
347.04
$465.82
2.01
463.81
231.36
25%
$232.91
2.01
230.90
115.68
Table 14 compares the benefits, with
nonfatal injuries included, to costs on a
per-unit basis.
TABLE 14—PER-APBR NET BENEFITS OF PROPOSED RULE
Portion of benefits achieved over the baseline
efficacy rate of redesigned APBRs
Per-unit net benefits
($, discounted at 3%)
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75%
Benefits ........................................................................................................................................
Costs ............................................................................................................................................
Net Benefits (Benefits-Costs) ......................................................................................................
B/C Ratio .....................................................................................................................................
B. Voluntary Standard
Based on staff’s evaluation of ASTM
F3186–17, the Commission
preliminarily determines that the
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voluntary standard is not likely to
eliminate or adequately reduce the
unreasonable risk of injury associated
with entrapments on APBRs. Further, as
discussed in section II of this preamble,
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50%
$1,157.74
3.34
1,154.41
347.04
$771.83
3.34
768.49
231.36
25%
$385.91
3.34
382.58
115.68
and Tabs C and D of the staff NPR
briefing package, staff collected sample
populations of APBR models and tested
them, first in 2018 through 2019, and
then again in 2021. In each instance, all
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APBRs examined by staff failed to
comply with one or more substantive
requirements of ASTM F3186–17.
CPSC staff also conducted informal
interviews with five firms in January
and February 2018, to determine if the
firms were familiar with the ASTM
standard, if they believed their products
conformed to the standard, and if they
believed other suppliers would conform
to the standard. Four firms indicated
they were familiar with the standard;
one thought that their products already
conformed; two indicated some
modifications were required to bring
their products into compliance; and two
expressed uncertainty whether they
would put warning labels required by
the voluntary standard on their product.
One firm expressed concern that if they
applied the required warnings to their
product and competitors did not, then
consumers would believe their products
were more hazardous than competing
APBRs without warning labels, causing
the firm to lose market share.
Accordingly, CPSC testing and
informal interviews show that there is
no substantial industry compliance with
the voluntary standard at this time.
Furthermore, substantial future industry
compliance appears unlikely because
firms have had several years to comply
with the voluntary standard and,
despite repeated outreach and testing,
no APBRs are known to comply with all
the requirements in the standard.
C. Alternatives to the Proposed Rule
The Commission considered six
alternatives to the proposed rule: (1)
take no regulatory action; (2) conduct a
recall of APBRs instead of promulgating
a final rule; (3) conduct an educational
campaign; (4) ban APBRs from the
market entirely; (5) require enhanced
safety warnings for APBRs; and (6) a
later effective date. The Commission
preliminarily finds that none of these
alternatives would adequately address
the hazards associated with APBRs.
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1. No Regulatory Action
If the Commission opted to take no
regulatory action, the industry
foreseeably would continue to fail to
address the entrapment hazards
associated with APBRs, and consumers
would remain at risk. The estimated
$298.11 million average annualized
societal costs would continue to be
incurred by consumers in the form of
deaths and injuries. For this reason, the
Commission does not find this
alternative would address the
unreasonable risk of injury associated
with APBRs.
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2. Conduct Recalls Instead of
Promulgating a Final Rule
The Commission could seek to recall
APBRs in use that present a substantial
product hazard. With this alternative,
manufacturers would continue to not
comply with the voluntary standard and
would not incur any costs to modify or
test APBRs to comply with the proposed
rule. However, recalls only apply to an
individual manufacturers and sellers of
APBRs, and do not extend to similar
products that fall within the scope of
ASTM 3186–17 and present the same
hazards. In addition, recalls occur only
after consumers have purchased and
used such products and may have been
killed or injured due to exposure to the
hazard. Finally, recalls cannot directly
prevent unsafe products from entering
the market. Therefore, much of the
estimated $298.11 million average
annualized societal costs would
continue to be incurred by consumers in
the form of deaths and injuries. For
these reasons, the Commission does not
find this alternative would address the
unreasonable risk of injury associated
with APBRs.
3. Conduct Education Campaigns
The Commission could issue news
releases or use other information and
marketing techniques to warn
consumers about entrapment hazards
associated with APBRs, instead of
issuing a mandatory rule. Information
and marketing campaigns, in
conjunction with CPSC recall actions,
may reduce the number of injuries and
societal costs associated with APBR
entrapment hazards. However,
education campaigns and recalls are not
likely to adequately reduce the risk of
injury from the entrapment hazard. As
noted above, CPSC has issued recall
announcements for APBRs in the past,
and these have not adequately
addressed the entrapment hazard.
Furthermore, recalls and associated
education campaigns occur only after
consumers have been exposed to the
hazard and potentially suffered injury or
death due as the result. Therefore, the
Commission does not find this
alternative would adequately address
the unreasonable risk of injury
associated with APBRs.
4. Total Ban of APBRs From the Market
The Commission could ban APBRs
sold as consumer products. However, in
considering this alternative, the
Commission must weigh both
quantifiable and unquantifiable factors
of the utility of APBR use to consumers.
APBRs provide benefits to users,
including mobility, ease of access to
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67603
beds, and the potential for at-home care.
Considering both the quantifiable and
unquantifiable costs and benefits, the
net benefit of this alternative is likely
less than that of the proposed rule.
However, the Commission seeks
comments on whether the proposed
adoption of the modified ASTM
standard sufficiently addresses the
hazard and whether a ban is warranted,
and if so, what the impact of a ban
would be on consumers (e.g., lost
consumer utility from not having the
product).
5. Enhanced Safety Warnings on APBRs
The Commission could require
enhanced safety warnings on APBRs.
Warning labels on APBRs have not
produced the desired results of reducing
entrapment injuries and deaths. Safety
warnings that rely on consumers to alter
their behavior to avoid the hazard are
less effective than designing the hazard
out of the product or guarding the
consumer from the hazard. Accordingly,
the Commission preliminarily finds that
warnings alone would not adequately
address the unreasonable risk of injury
associated with APBRs. Although
warnings and instructions have limited
effectiveness, the labeling, warning, and
instructional literature requirements of
ASTM F3186–17 do beneficially address
the risk of injuries and deaths associated
with APBRs and CPSC proposes that
they be adopted with modifications set
forth in the proposed rule.
6. Later Effective Date
The Commission could issue the new
rule with an introduction time greater
than the 30 days recommended in this
proposed rule. APBRs that present an
unreasonable risk of death or injury
from entrapment would continue to
enter the marketplace during that time.
Delaying the benefits of the rule likely
results in higher social costs, in
exchange for limited benefits to
producers, who would still be required
to revise their APBR products.
Furthermore, manufacturers of APBRs
have long had notice of the
requirements of ASTM F3186–17 and,
as staff investigation confirms, are
familiar with the core requirements of
the proposed rule. For this reason, staff
does not recommend this alternative.
VII. Initial Regulatory Flexibility
Analysis
Whenever an agency publishes an
NPR, section 603 of the Regulatory
Flexibility Act (RFA), 5 U.S.C. 601–612,
requires agencies to prepare an initial
regulatory flexibility analysis (IRFA),
unless the head of the agency certifies
that the rule will not have a significant
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economic impact on a substantial
number of small entities. The IRFA, or
a summary of it, must be published in
the Federal Register with the proposed
rule. Under section 603(b) of the RFA,
each IRFA must address:
(1) a description of why action by the
agency is being considered;
(2) a succinct statement of the
objectives of, and legal basis for, the
proposed rule;
(3) a description and, where feasible,
an estimate of the number of small
entities to which the proposed rule will
apply;
(4) a description of the projected
reporting, recordkeeping, and other
compliance requirements of the
proposed rule, including an estimate of
the classes of small entities which will
be subject to the requirement and the
type of professional skills necessary for
preparation of the report or record; and
(5) an identification, to the extent
practicable, of all relevant Federal rules
which may duplicate, overlap, or
conflict with the proposed rule.
The IRFA must also describe any
significant alternatives to the proposed
rule that would accomplish the stated
objectives and that minimize any
significant economic impact on small
entities. Staff’s initial regulatory
flexibility analysis is provided in Tab H
of Staff’s NPR briefing package.
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A. Reason for Agency Action
The purpose of the proposed rule is
to reduce deaths and injuries resulting
from entrapment on APBRs. CPSC staff
identified 310 fatal injuries associated
with APBR hazards in years 2003
through 2021. Although staff’s
assessment with ASTM F3186–17
shows that, with modifications, it would
adequately reduce the unreasonable risk
of injury associated with APBRs, there
is no compliance with the voluntary
standard. Accordingly, the Commission
preliminarily finds that a mandatory
rule is reasonably necessary to reduce
the unreasonable risk of injury of
entrapment hazards from APBRs.
B. Objectives and Legal Basis for the
Rule
The Commission proposes this rule to
reduce the risk of death and injury
associated with APBRs. The proposed
rule is promulgated under the authority
in sections 7 and 9 of the CPSA.
C. Small Entities to Which the Rule Will
Apply
The proposed rule would apply to all
manufacturers and importers of APBRs.
Staff identified seven U.S. APBR
manufacturers that meet the SBA
criteria for small businesses. Importers
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of APBRs could be wholesale or retail
distributers. Staff identified one U.S.
APBR firm in these categories that could
be considered a small business.
D. Compliance, Reporting, and RecordKeeping Requirements of Proposed Rule
The proposed rule would establish a
performance requirement for APBRs and
test procedures that suppliers would
have to meet to sell APBRs in the
United States. Specifically, the NPR
would require APBRs sold in the United
States to comply with the ASTM F3186–
17 standard, with the proposed
modifications. CPSC expects most APBR
manufacturers, including those
considered small by SBA standards,
would incur costs associated with
bringing their APBRs into compliance
with the proposed rule, as well as costs
related to testing and issuing a General
Certificate of Conformity (GCC).
In accordance with section 14 of the
CPSA, manufacturers would have to
issue a GCC for each APBR model,
certifying that the model complies with
the proposed rule. According to section
14 of the CPSA, GCCs must be based on
a test of each product, or a reasonable
testing program; and GCCs must be
provided to all distributors or retailers
of the product. The manufacturer would
have to comply with 16 CFR part 1110
concerning the content of the GCC,
retention of the associated records, and
all other applicable requirements.
E. Federal Rules That May Duplicate,
Overlap, or Conflict With the Proposed
Rule
CPSC has not identified any other
Federal rules that duplicate, overlap, or
conflict with the proposed rule.
F. Potential Impact on Small Entities
Generally, CPSC considers an impact
to be potentially significant if it exceeds
1 percent of firm’s gross revenue. Staff
identified seven APBR manufacturers
that meet SBA size standards for small
businesses. Staff applied both the permodel and per-unit costs to each
manufacturer’s number of models and
estimated unit sales in 2021. Staff found
that the initial cost to comply with the
proposed rule exceeds one percent of
reported annual revenue for three of the
seven manufacturers identified as small
businesses. For these three APBR
manufacturers, the economic impact of
the proposed rule is expected to be
significant. As discussed in Tab G of
Staff’s NPR Briefing Package, to achieve
compliance with the proposed rule’s
performance requirements, APBR
suppliers would incur costs from
redesigning, retooling, and testing. Staff
estimates this cost to be $42,239 per
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model in the first year. Staff estimates
the additional production cost for labor
and material to be $10.01 per unit
produced in the first year, of which
$7.74 is expected to be passed on to the
consumer.
Staff identified one possible importer
of APBRs from foreign suppliers that
would be considered small businesses
based on SBA size standards. Small
importers would be adversely impacted
by the proposed rule if its foreign
supplier withdrew from the U.S. market,
rather than incur the cost of compliance.
Small importers would also be
adversely impacted if foreign
manufacturers failed to provide a GCC
and the importers had to perform their
own testing for compliance. If sales of
APBRs are a substantial source of the
importer’s business, and the importer
cannot find an alternative supplier of
APBRs, the economic impact on these
firms may be significant. However, staff
estimates the U.S. APBR market will
grow at annual rate of approximately
2.01 percent over the next 20 years. It
is unlikely that foreign manufacturers
would exit a market growing at this rate.
APBR importers also import other
medical equipment, devices, and
supplies. For these firms, any decline in
APBR sales and revenue may be
partially or fully offset by increasing
sales and revenues of these other
products. Small importers would be
responsible for issuing a GCC certifying
that their APBRs comply with the rule’s
requirements. However, importers may
issue GCCs based upon certifications
provided by or testing performed by
their suppliers. Based on an estimated
$4,532 per model for testing, the impact
on small importers whose suppliers
provide GCCs is unlikely to be
significant.
VIII. Incorporation by Reference
The Commission proposes to
incorporate by reference ASTM F3186–
17, Standard Specification for Adult
Portable Bed Rails and Related
Products. The Office of the Federal
Register (OFR) has regulations regarding
incorporation by reference. 1 CFR part
51. Under these regulations, agencies
must discuss, in the preamble, ways in
which the material the agency
incorporates by reference is reasonably
available to interested parties, and how
interested parties can obtain the
material. In addition, the preamble must
summarize the material. 1 CFR 51.5(b).
In accordance with the OFR
regulations, section IV. of this preamble
summarizes the major provisions of
ASTM F3186–17 that the Commission
proposes to incorporate by reference
into 16 CFR part 1270. The standard
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itself is reasonably available to
interested parties. Until the end of the
comment period, a read-only copy of
ASTM F3186–17 is available for
viewing, at no cost, on ASTM’s website
at: https://www.astm.org/CPSC.htm.
Once the rule takes effect, a read-only
copy of the standard will be available
for viewing, at no cost, on the ASTM
website at: https://www.astm.org/
READINGLIBRARY/. Interested parties
can also schedule an appointment to
inspect a copy of the standard at CPSC’s
Office of the Secretary, U.S. Consumer
Product Safety Commission, 4330 East
West Highway, Bethesda, MD 20814,
telephone: (301) 504–7479; email: cpscos@cpsc.gov. Interested parties can
purchase a copy of ASTM F3186–17
from ASTM International, 100 Barr
Harbor Drive, P.O. Box C700, West
Conshohocken, PA 19428–2959 USA;
telephone: (610) 832–9585;
www.astm.org.
IX. Environmental Considerations
Generally, the Commission’s
regulations are considered to have little
or no potential for affecting the human
environment, and environmental
assessments and impact statements are
not usually required. See 16 CFR
1021.5(a). The proposed rule is not
expected to have an adverse impact on
the environment and is considered to
fall within the ‘‘categorical exclusion’’
for the purposes of the National
Environmental Policy Act. 16 CFR
1021.5(c).
X. Preemption
Executive Order (E.O.) 12988, Civil
Justice Reform (Feb. 5, 1996), directs
agencies to specify the preemptive effect
of a rule in the regulation. 61 FR 4729
(Feb. 7, 1996). The proposed regulation
for APBRs is issued under authority of
the CPSA. 15 U.S.C. 2051–2089. Section
26 of the CPSA provides that ‘‘whenever
a consumer product safety standard
under this Act is in effect and applies
to a risk of injury associated with a
consumer product, no State or political
subdivision of a State shall have any
authority either to establish or to
continue in effect any provision of a
safety standard or regulation which
prescribes any requirements as to the
performance, composition, contents,
design, finish, construction, packaging
or labeling of such product which are
designed to deal with the same risk of
injury associated with such consumer
product, unless such requirements are
identical to the requirements of the
Federal Standard.’’ Id. 2075(a). Thus,
the proposed rule for APBRs, if
finalized, would preempt non-identical
state or local requirements for APBRs
designed to protect against the same risk
of injury.
States or political subdivisions of a
state may apply for an exemption from
preemption regarding a consumer
product safety standard, and the
Commission may issue a rule granting
the exemption if it finds that the state
or local standard: (1) provides a
significantly higher degree of protection
from the risk of injury or illness than the
CPSA standard, and (2) does not unduly
burden interstate commerce. Id. 2075(c).
XI. Paperwork Reduction Act
This proposed rule contains
information collection requirements that
are subject to public comment and
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA). 44 U.S.C.
3501–3520. We describe the provisions
in this section of the document with an
67605
estimate of the annual reporting burden.
Our estimate includes the time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing each
collection of information.
CPSC particularly invites comments
on: (1) whether the collection of
information is necessary for the proper
performance of the CPSC’s functions,
including whether the information will
have practical utility; (2) the accuracy of
the CPSC’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (4) ways to reduce the burden
of the collection of information on
respondents, including the use of
automated collection techniques, when
appropriate, and other forms of
information technology; and (5)
estimated burden hours associated with
label modification, including any
alternative estimates.
Title: Safety Standard for Adult Portable
Bed Rails
Description: The proposed rule would
require each APBR to comply with
ASTM F3186–17, Standard
Specification for Adult Portable Bed
Rails and Related Products, with
modifications. Sections 9, 10, and 11 of
ASTM F3186–17 contain requirements
for labels, warnings and instructional
literature.
Description of Respondents: Persons
who manufacture or import adult
portable bed rails.
Staff estimates the burden of this
collection of information as follows in
Table 15:
TABLE 15—ESTIMATED ANNUAL REPORTING BURDEN
Number
of respondents
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Burden type
Frequency of
responses
Total annual
responses
Hours
per response
Total burden
hours
Annual cost
Labeling ....................................................
Instructional Literature .............................
12
12
6
6
72
72
8
24
576
1,728
$20.304
60,912
Total Burden .....................................
........................
........................
........................
........................
2,304
81,216
Our estimate is based on the
following. There are 12 known entities
supplying APBRs to the U.S. market. On
average, each entity supplies six APBR
models to the market. All 12 entities are
assumed to already use labels on both
their products and packaging. However,
none of the APBR models tested comply
with ASTM F3186–17 labeling and
informational requirements. CPSC
therefore expects all entities will need
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to make modifications to their existing
labels. The estimated time required to
make these modifications is about eight
hours per model. Each entity supplies
an average of six different APBR
models. Therefore, the estimated burden
associated with labels is 576 hours (12
entities × 6 models per entity × 8 hours
per model = 576 hours). We estimate the
hourly compensation for the time
required to create and update labels is
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$35.25 (U.S. Bureau of Labor Statistics,
‘‘Employer Costs for Employee
Compensation,’’ March 2022, total
compensation for all sales and office
workers in goods-producing private
industries: www.bls.gov/ncs/.)
Therefore, the estimated annual cost to
industry associated with the labeling
requirements is $20,304 ($35.25 per
hour × 576 hours). There are no
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operating, maintenance, or capital costs
associated with the collection.
The proposed rule would also require
instructions to be supplied with the
product. Under the OMB’s regulations
(5 CFR 1320.3(b)(2)), the time, effort,
and financial resources necessary to
comply with a collection of information
that would be incurred by persons in
the ‘‘normal course of their activities’’
are excluded from a burden estimate,
where an agency demonstrates that the
disclosure activities required to comply
are ‘‘usual and customary.’’ APBRs
require installation on an existing bed,
which implies instructions for proper
use, fit, and position on a bed, as well
as cleaning are necessary. While many
APBR entities already provide some
instructional material, CPSC expects all
will need to make some modifications to
existing material. The estimated time to
modify the instructional material is 24
hours per model. Each entity supplies
an average of six different APBR
models. Therefore, the estimated burden
associated with instructional literature
is 1,728 hours (12 entities × 6 models
per entity × 24 hours per model). We
estimate the hourly compensation for
the time required to create and update
instructional material is $35.25 (U.S.
Bureau of Labor Statistics, ‘‘Employer
Costs for Employee Compensation,’’
March 2022), total compensation for all
sales and office workers in goodsproducing private industries:
www.bls.gov/ncs/). Therefore, the
estimated annual cost to industry
associated with the instructional
material requirements is $60,912
($35.25 per hour × 1,728 hours). There
are no operating, maintenance, or
capital costs associated with the
collection.
Based on this analysis, the proposed
standard for APBRs would impose a
burden to industry of 2,304 hours, at an
estimated cost of $81,216 annually
($20,304 + $60.912). Existing APBR
entities would incur these costs in the
first year following the proposed rule’s
effective date. In subsequent years, costs
could be less, depending on the number
of new APBR models introduced by
existing entities and/or by entities
entering the APBR market. As required
under the PRA (44 U.S.C. 3507(d)),
CPSC has submitted the information
collection requirements of this proposed
rule to the OMB for review. Interested
persons are requested to submit
comments regarding information
collection by December 9, 2022, to the
Office of Information and Regulatory
Affairs, OMB as described under the
ADDRESSES section of this document.
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XII. Certification
Section 14(a) of the CPSA requires
that products subject to a consumer
product safety rule under the CPSA, or
to a similar rule, ban, standard or
regulation under any other act enforced
by the Commission, must be certified as
complying with all applicable CPSCenforced requirements. 15 U.S.C.
2063(a). A final rule on APBRs would
subject them to this requirement.
XIII. Effective Date
The Administrative Procedure Act
(APA) generally requires that the
effective date of a rule be at least 30
days after publication of a final rule. 5
U.S.C. 553(d). Section 9(g)(1) of the
CPSA states that a consumer product
safety rule shall specify the date such
rule is to take effect, and that the
effective date must be at least 30 days
after promulgation but cannot exceed
180 days from the date a rule is
promulgated, unless the Commission
finds, for good cause shown, that a later
effective date is in the public interest
and publishes its reasons for such
finding.
If finalized, the Commission proposes
an effective date of 30 days after
publication of the final rule. ASTM
F3186–17 has been in existence since
August 2017, and agency staff has
conducted outreach efforts to make
firms aware of the requirements of the
standard. Accordingly, manufacturers
already are familiar with ASTM F3186–
17 and should be ready and able to
comply with the requirements included
in the proposed rule. Therefore, the
Commission preliminarily finds a 30day effective date following publication
of the rule in the Federal Register
appropriate to address the risks of
APBRs expeditiously. The rule would
apply to all APBRs manufactured after
the effective date. However, the
Commission requests comments on the
proposed effective date. The CPSC is
proposing an anti-stockpiling provision
to prevent firms from manufacturing
large quantities of non-compliant
APBRs before the rule takes effect and
seeks comment on this provision.
XIV. Request for Comments
We invite all interested persons to
submit comments on any aspect of the
proposed rule. Specifically, the
Commission seeks comments on the
following:
• Information regarding any analysis
and/or tests done on APBRs in relation
to the risks of injury or death they
present;
• Information regarding any potential
costs or benefits of the proposed rule
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Sfmt 4702
that were not included the foregoing
preliminary regulatory analysis;
• Information regarding the number
of small businesses impacted by the
proposed rule and the magnitude of the
impacts of the proposed rule;
• The testing procedures and
methods of the proposed rule and
whether they sufficiently reduce the risk
associated with APBRs, or whether
other measures are necessary and
information demonstrating how these
measures address the identified risks;
• Potential alternatives to APBRs if
they are banned, and the impact that a
ban on APBRs would have on
consumers (e.g., lost consumer utility
from not having the product);
• Any qualitative or quantitative
evidence concerning the utility that
APBRs have for consumers relative to
alternative products that might be used
as substitutes in the event APBRs are
banned; and
• The appropriateness of the 30-day
effective date, and a quantification of
how a 30-day effective date would affect
the benefits and costs of the proposed
rule.
XV. Notice of Opportunity for Oral
Presentation
Section 9 of the CPSA requires the
Commission to provide interested
parties ‘‘an opportunity for oral
presentation of data, views, or
arguments.’’ 15 U.S.C. 2058(d)(2). The
Commission must keep a transcript of
such oral presentations. Id. Any person
interested in making an oral
presentation must contact the
Commission, as described under the
DATES and ADDRESSES section of this
document.
XVI. Promulgation of a Final Rule
Section 9(d)(1) of the CPSA requires
the Commission to promulgate a final
consumer product safety rule within 60
days of publishing a proposed rule. 15
U.S.C. 2058(d)(1). Otherwise, the
Commission must withdraw the
proposed rule if it determines that the
rule is not reasonably necessary to
eliminate or reduce an unreasonable
risk of injury associated with the
product or is not in the public interest.
Id. However, the Commission can
extend the 60-day period, for good cause
shown, if it publishes the reasons for
doing so in the Federal Register. Id.
The Commission finds that there is
good cause to extend the 60-day period
for this rulemaking. Under both the
APA and the CPSA, the Commission
must provide an opportunity for
interested parties to submit written
comments on a proposed rule. 5 U.S.C.
553; 15 U.S.C. 2058(d)(2). The
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Commission is providing 60 days for
interested parties to submit written
comments. A shorter comment period
may limit the quality and utility of
information CPSC receives in
comments, particularly for areas where
it seeks data and other detailed
information that may take time for
commenters to compile. Additionally,
the CPSA requires the Commission to
provide interested parties with an
opportunity to make oral presentations
of data, views, or arguments. 15 U.S.C.
2058. This requires time for the
Commission to arrange a public meeting
for this purpose and provide notice to
interested parties in advance of that
meeting, if any interested party requests
the opportunity to present such
comments. After receiving written and
oral comments, CPSC staff must have
time to review and evaluate those
comments.
These factors make it impractical for
the Commission to issue a final rule
within 60 days of this proposed rule.
Moreover, issuing a final rule within 60
days of the NPR may limit commenters’
ability to provide useful input on the
rule, and CPSC’s ability to evaluate and
take that information into consideration
in developing a final rule. Accordingly,
the Commission finds that there is good
cause to extend the 60-day period for
promulgating the final rule after
publication of the proposed rule.
List of Subjects in 16 CFR Part 1270
Administrative practice and
procedure, Consumer protection,
Incorporation by reference, Adult
portable bed rails.
■ For the reasons discussed in this
preamble, the Commission proposes to
amend Title 16 of the Code of Federal
Regulations by adding part 1270 to read
as follows:
PART 1270—SAFETY STANDARD FOR
ADULT PORTABLE BED RAILS
khammond on DSKJM1Z7X2PROD with PROPOSALS
Sec.
1270.1 Scope, application, and effective
date.
1270.2 Requirements for adult portable bed
rails.
1270.3 Prohibited stockpiling.
1270.4 Findings.
Authority: 15 U.S.C. 2056, 15 U.S.C 2058,
and 5 U.S.C. 553.
§ 1270.1
date.
Scope, application, and effective
This part 1270 establishes a consumer
product safety standard for adult
portable bed rails manufactured after
[DATE 30 DAYS AFTER DATE OF
PUBLICATION OF THE FINAL RULE
IN THE FEDERAL REGISTER].
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§ 1270.2 Requirements for adult portable
bed rails.
(a) Except as provided in paragraph
(b) of this section, each adult portable
bed rail must comply with all applicable
provisions of ASTM F3186–17,
Standard Specification for Adult
Portable Bed Rails and Related
Products, approved on August 1, 2017.
The Director of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. A read-only copy of the
standard is available for viewing on the
ASTM website at https://www.astm.org/
READINGLIBRARY/. You may obtain a
copy from ASTM International, 100 Barr
Harbor Drive, P.O. Box C700, West
Conshohocken, PA 19428–2959;
telephone (610) 832–9585;
www.astm.org. You may inspect a copy
from the Office of the Secretary, U.S.
Consumer Product Safety Commission,
4330 East West Highway, Bethesda, MD
20814, telephone (301) 504–7479, email
cpsc-os@cpsc.gov, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
email fr.inspection@nara.gov, or go to:
www.archives.gov/federal-register/cfr/
ibr-locations.html.
(b) Comply with the ASTM F3186–17
standard with the following changes:
(1) In addition to complying with
section 3.1.7 of ASTM F3186–17, each
adult portable bed rail must comply
with the following:
(i) 3.1.8 Initial assembly. The first
assembly of the product components
after purchase, and prior to installing on
the bed.
(ii) 3.1.9 Initial installation. The first
installation of the product onto a bed or
mattress.
(iii) 3.1.10 Installation component.
Component(s) of the bed rail that is/are
specifically designed to attach the bed
and typically located under the mattress
when in the manufacturer’s
recommended use position.
(2) Instead of complying with section
6.1.3 of ASTM F3186–17, comply with
the following:
(i) Under section 6.1.3, permanently
attached retention system components
shall not be able to be removed without
the use of a tool after initial assembly.
(ii) [Reserved]
(3) In addition to complying with
section 6.2.1 of ASTM F3186–17,
comply with the following:
(i) Under section 6.2.1.1, if the
manufacturer does not recommend a
specific applicable range of mattress
heights or thicknesses, the test
personnel shall choose a mattress that
provides the most severe condition per
test requirement. If the product has
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Sfmt 4702
67607
adjustable settings, and the
manufacturer does not recommend
orienting or adjusting features on the
product in a specific manner, the testers
shall adjust the product to the most
severe condition per test requirement.
(ii) [Reserved]
(4) Instead of complying with section
6.3.3 of ASTM F3186–17, comply with
the following:
(i) 6.3.3. Zone 3. When tested in
accordance with section 8.4.5, the
horizontal centerline on the face of the
4.7 in (120 mm) end of the test probe
(see 7.2) shall be above the highest point
of the uncompressed mattress.
(ii) [Reserved]
(5) Instead of complying with section
6.4.1 of ASTM F3186–17, comply with
the following:
(i) Under section 6.4.1, holes or slots
that extend entirely through a wall
section of any rigid material less than
0.375 in (9.53 mm) thick and admit a
0.210 in (5.33 mm) diameter rod shall
also admit a 0.375 in (9.53 mm)
diameter rod. Holes or slots that are
between 0.210 in (5.33 mm) and 0.375
in (9.53 mm) and have a wall thickness
less than 0.375 in (9.53 mm) but are
limited in depth to 0.375 in (9.53 mm)
maximum by another rigid surface shall
be permissible (see Opening Example in
Figure 2 of ASTM F3186–17).
(ii) [Reserved]
(6) Instead of complying with section
6.5.1 of ASTM F3186–17, comply with
the following:
(i) Under section 6.5.1, any structural
components and retention system
components of a product covered by
this specification that require consumer
assembly or adjustment, or components
that may be removed by the consumer
without the use of a tool, shall not be
able to be misassembled when evaluated
to 6.5.2.
(ii) [Reserved]
(7) Instead of complying with section
6.5.2 of ASTM F3186–17, comply with
the following:
(i) 6.5.2 Determining misassembled
product. A product covered by this
specification shall be considered
misassembled if it appears to be
functional under any condition and it
does not meet the requirements of
sections 6.1–6.4.
(ii) [Reserved]
(8) In addition to complying with
section 7.1 of ASTM F3186–17, comply
with the following:
(i) Under section 7.1.3, mattress
thickness ranges used for testing may be
up to 1.5 in (38 mm) larger or smaller
than the range specified by the
manufacturer. If the manufacturer does
not recommend a particular range of
mattress heights, the testers shall choose
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Note 1 to paragraph (b)(8)(i): The
technology and consumer preferences for
bedding are highly variable and continuously
changing. Therefore, they cannot be
reasonably accounted for within this
standard. Test facilities and personnel should
consider current bedding trends and all types
of mattresses that may foreseeably be used
with the product when making a test mattress
selection.
(ii) [Reserved]
(9) In addition to complying with
section 7.2 of ASTM F3186–17, comply
with the following:
(i) 7.2. Entrapment test probe. The test
probe shall be as described in the FDA
Guidance Document, ‘‘Hospital Bed
System Dimensional and Assessment
Guidance to Reduce Entrapment,’’
which can be found at: www.fda.gov/
regulatory-information/search-fdaguidance-documents/hospital-bedsystem-dimensional-and-assessmentguidance-reduce-entrapment. The test
probe can be independently
manufactured per the dimensional
constraints in the guidance document or
purchased from Bionix, 5154 Enterprise
Blvd., Toledo, OH 43612, 800–551–
7096, www.bionix.com. Videos
illustrating use of the test probe are
available at: www.youtube.com/c/
BionixLLC/search.
(ii) [Reserved]
Highest Point of
Uncompressed
Mattress
(10) Instead of complying with Note 1
in section 8.4 of ASTM F3186–17,
comply with the following:
Note 1 to paragraph (b)(10)(i): The tests
described in this section are similar to those
described in the referenced FDA Guidance
Document.
(11) Instead of complying with section
8.4.3.4 of ASTM F3186–17, comply with
the following:
(i) Under section 8.4.3.4, if the test
probe does not pull through, freely
attach the force gauge and exert a 22.5
lbf (100 N) pulling force along the axis
of the cone, perpendicular to the 2.4 in
(60 mm) cylindrical end of the
entrapment test tool. If the 4.7 in (120
mm) end of the cone does not enter any
of the openings, this space passes the
test. If the 4.7 in (120 mm) end of the
test probe cone does enter any of the
openings, this space fails the test.
(ii) [Reserved]
(12) Instead of complying with section
8.4.4.3 of ASTM F3186–17, comply with
the following:
(i) Under section 8.4.4.3, insert the 2.4
in (60 mm) end of the cone
perpendicular into the opening. Slide
the cone into the opening until it is in
full contact with the product. The
mattress shall only be compressed by
the weight of the cone.
(ii) [Reserved]
Centerline
Highest Point of
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a: Zone 3 Pass Criteria
(Centerline above highest point of uncompressed
mattress)
(ii) [Reserved]
(15) In addition to complying with
section 8.6.3 of ASTM F3186–17, define
‘‘free end’’ in a note as follows:
Note 1 to Paragraph (b)(15)(i): The ‘‘free
end’’ is defined as the location on the
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(16) Instead of complying with section
9.1.1.3 of ASTM F3186–17, comply with
the following:
Frm 00038
Fmt 4702
Centerline
b: Zone 3 Fail Criteria
(Centerline below highest point of
uncompressed mattress)
retention system that is designed to produce
a counter force; it may be a single distinct
point or a location on a loop.
PO 00000
(13) Instead of complying with section
8.4.4.4 of ASTM F3186–17, comply with
the following:
(i) Under section 8.4.4.4, if the test
probe does not pull through freely use
the force gauge to exert a 22.5 lbf (100
N) pulling force along the axis of the
cone, perpendicular to the 2.4 in (60
mm) cylindrical end of cone.
(ii) Under section 8.4.4.5, if a
horizontal section of the rail greater
than 4.7 in exists along the bottom of
the rail, that section must also meet the
Zone 2 requirements.
(14) Instead of complying with section
8.4.5.4 of ASTM F3186–17, comply with
the following:
(i) Under section 8.4.5.4, turn the
cone until the line on the face of the 4.7
in (120 mm) end is horizontal and let
the cone sink into the space by its own
weight.
(A) If the line on the face of the 4.7
in (120 mm) end of the cone is above the
highest point of the uncompressed
mattress, as shown in Figure 1 to
paragraph (b)(14) of this section, the
space passes the test.
(B) If the line on the face of the 4.7
in (120 mm) end of the cone is at or
below the highest point of the
uncompressed mattress, as shown in
Figure 1 to paragraph (b)(14) of this
section, the space fails the test.
Figure 1 to paragraph (b)(14) of this
section: Zone 3 test: (a) Pass, (b) Fail
Sfmt 4702
(i) Under section 9.1.1.3, that the
product is to be used only with the type
and size of mattress and bed, including
the range of thickness of mattresses,
specified by the manufacturer of the
product. If beds with head or footboards
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EP09NO22.005
a mattress that provides the most severe
condition per test requirement.
Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Proposed Rules
are allowed, the distance between the
head or footboard and the placement of
the product shall be indicated to be
>12.5 in (318 mm).
(ii) [Reserved]
(17) Instead of complying with section
9.2.5 of ASTM F3186–17, comply with
the following:
(i) Under section 9.2.5, each product’s
retail package and instructions shall
include the warning statements in
67609
Figure 2 to paragraph (b)(17)(i) of this
section.
Figure 2 to paragraph (b)(17)(i): Warning
Statements for Product Retail Package
and Instructions
AWARNING
ENTRAPMENT, STRANGULATION, SUFFOCATION AND FALL HAZARDS
Gaps in and around this product can entrap and kill. People with Alzheimer's disease
or dementia, or those who are sedated, confused, or frail are at increased risk of
entrapment and strangulation. People attempting to climb over this product are at
increased risk of injury or death from falls. Always make sure this product is properly
secured to bed. If product can move away from bed or mattress, it can lead to
entrapment and death.
(ii) [Reserved]
(18) Instead of complying with section
9.2.7 of ASTM F3186–17, comply with
the following:
(i) Under section 9.2.7, at least one
installation component of the product
must be labeled with the entrapment
warning in Figure 3 to paragraph
(b)(18)(i).
Figure 3 to paragraph (b)(18)(i):
Entrapment Warning
(ii) [Reserved]
(19) Instead of complying with section
11.1.1.3 of ASTM F3186–17, comply
with the following:
(i) Under section 11.1.1.3, in addition
to contacting the manufacturer directly,
consumers should report problems to
the CPSC at its website
SaferProducts.gov or call 1–800–638–
2772, or to the FDA at 1–800–332–1088.
(ii) [Reserved]
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§ 1270.3
Prohibited stockpiling.
(a) Prohibited acts. Manufacturers and
importers of adult portable bed rails
(APBRs) shall not manufacture or
import APBRs that do not comply with
the requirements of this part in any 1month period between [DATE OF
PUBLICATION OF FINAL RULE] and
[EFFECTIVE DATE OF FINAL RULE] at
a rate that is greater than 105 percent of
the rate at which they manufactured or
imported APBRs during the base period
for the manufacturer or importer.
(b) Base period. The base period for
APBRs is the calendar month with the
median manufacturing or import
volume within the last 13 months
immediately preceding the month of
promulgation of the final rule.
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§ 1270.4
Findings.
(a) General. The Consumer Product
Safety Act (CPSA) requires the
Commission to make certain findings
when issuing a consumer product safety
standard. 15 U.S.C. 2058(f). This section
discusses preliminary support for those
findings.
(b) Degree and Nature of the Risk of
Injury. Between January 2003 and
December 2021, the Consumer Product
Safety Risk Management System
(CPSRMS) injury cases showed there
were 332 incident reports concerning
adult portable bed rails (APBR). Of
these, 310 were reports of fatalities, and
22 were nonfatal. Rail entrapment is the
most prevalent hazard pattern among
the incidents, accounting for more than
90 percent of all fatal incidents. There
were 284 fatal incidents related to rail
entrapment. Falls were the second most
common hazard pattern in the incident
data, accounting for 25 incidents (8
percent). There were 23 fatalities from
falls. Most of the incidents were
identified from death certificates,
medical examiner reports, or coroner
reports. Because death certificate data
often have a lag time of around two to
three years from the date of reporting to
CPSC, data collection is ongoing and
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incidents for 2020, 2021, and 2022 are
likely to increase.
(c) Number of Consumer Products
Subject to the Rule. An estimated 12
firms supply 65 distinct APBR models.
In 2021, the number of APBRs sold was
approximately 180,000 units.
(d) Need of the Public for the Products
and Probable Effect on Utility, Cost, and
Availability of the Product. (1) APBRs
are installed or used alongside a bed by
consumers to: reduce the risk of falling
from the bed; assist the consumer in
repositioning in the bed; or assist the
consumer in transitioning into or out of
the bed. The market for APBRs is
expected to grow at an average rate of
2.01 percent between 2024 and 2053 as
a result of an aging U.S. population
seeking to avoid institutional medical
care. Without a mandatory standard,
assuming the rates of incidents, per
million APBRs, stay constant, this
growth in the industry would lead to an
average of 32 entrapment deaths per
year.
(2) The cost of compliance to address
entrapment hazards includes the costs
manufacturers incur to redesign existing
models and produce new designs to
comply with the mandatory standard, as
well as the cost of producing the
redesigned APBR. Manufacturers would
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A WARNING - ENTRAPMENT HAZARD
NEVER use product without properly securing it to bed. Incorrect installation
can allow product to move away from mattress, bed frame and/or head or foot
boards, which can lead to entrapment and death.
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Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Proposed Rules
likely incur expenditures in design
labor, design production, design
validation, and compliance testing.
Manufacturers would also be required to
upgrade all new APBR designs. CPSC
estimates these costs to be $42,239 per
model in the first year. Once existing
models have been redesigned with a
working solution, however, new models
can adapt at a minimal cost.
Manufacturers can transfer some, or all,
of the increased production cost to
consumers through price increases. In
the first year, producer manufacturing
costs are expected to increase by $5.40
per APBR, of which $4.00 per APBR is
expected to be passed on to the
consumer in the form of higher prices.
At the margins, some producers may
exit the market because their increased
marginal costs now exceed the increase
in market price. Likewise, a very small
fraction of consumers would now
probably be excluded from the market
because the increased market price
exceeds their personal price threshold
for purchasing an APBR.
(e) Any Means to Achieve the
Objective of the Proposed Rule, While
Minimizing Adverse Effects on
Competition and Manufacturing. (1) The
proposed requirement of the rule
achieves the objective of reducing
entrapment hazards on APBRs while
minimizing the effect on competition
and manufacturing. Because the
proposed rule is based on an existing
voluntary standard, and because of
CPSC’s outreach efforts, APBR
manufacturers are generally aware of the
requirements. The proposed rule would
apply to all manufacturers and
importers of APBRs. Manufacturers can
transfer some, or all, of the increased
production cost to consumers through
price increases.
(2) The Commission considered
alternatives to the proposed rule to
minimize impacts on competition and
manufacturing including:
(i) Take no regulatory action;
(ii) Conduct a recall of APBRs instead
of promulgating a final rule;
(iii) Conduct an educational
campaign;
(iv) Require enhanced safety
warnings; and
(v) Longer effective date.
(3) However, the Commission
determines preliminarily that none of
these alternatives would adequately
reduce the risk of deaths and injuries
associated with APBR entrapment that
the proposed rule addresses.
(f) Unreasonable Risk. Incident data
show 284 fatal incidents related to rail
entrapment. This hazard pattern is the
most prevalent among the APBR
incidents, accounting for more than 90
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percent of all fatal incidents. There were
also 23 fatalities related to falls. The
incident data show that these incidents
continue to occur and are likely to
increase because APBR manufacturers
do not comply with the voluntary
standard and the market for APBRs is
forecast to grow. The proposed
mandatory standard would establish
performance requirements to address
the risk of entrapments associated with
APBRs. Given the fatal and serious
injuries associated with entrapments on
APBRs, the Commission preliminarily
finds that this rule is necessary to
address the unreasonable risk of injury
associated with APBR entrapments.
(g) Public Interest. The proposed rule
is intended to address an unreasonable
risk of entrapments associated with
APBRs. Adherence to the requirements
of the proposed rule would reduce
deaths and injuries from APBR
entrapment incidents; thus, the rule is
in the public interest.
(h) Voluntary Standards. Under
section 9(f)(3)(D) of the CPSA, if a
voluntary standard addressing the risk
of injury has been adopted and
implemented, then the Commission
must find that: the voluntary standard is
not likely to eliminate or adequately
reduce the risk of injury, or substantial
compliance with the voluntary standard
is unlikely.
(1) The Commission preliminarily
determines that the voluntary standard
is not likely to eliminate or adequately
reduce the unreasonable risk of injury
associated with entrapments on APBRs.
Accordingly, the Commission is
proposing to adopt the voluntary
standard with specified modifications
necessary to improve safety and
adequately reduce the unreasonable risk
of injury associated with entrapment on
APBRs. Entrapment is the most
prevalent hazard pattern among the
deaths and injuries associated with
APBRs. The entrapment test methods
specified in the voluntary standard
require products to be tested to assess
the potential for entrapment in four
different zones. These zones were
identified by the FDA in its 2006
guidance document, Hospital Bed
System Dimensional and Assessment
Guidance to Reduce Entrapment (FDA,
2006) and used in the voluntary
standard, as potential areas of
entrapment for APBRs. The FDA’s
guidance is based on recommendations
from the Hospital Bed Safety Workgroup
(HBSW), which was formed in 1999 to
address reports of patient entrapment.
The voluntary standard specifies the
FDA probe to test entrapment zones.
The probe design is based on the
anthropometric dimensions of key body
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Sfmt 4702
parts, including the head, neck, and
chest of at-risk adults. The four
entrapment zones required to be tested
are:
(i) Within the product;
(ii) Between rail support(s) and the
bed mattress, when applicable, under
the product;
(iii) Between the product and the
mattress; and
(iv) Between the underside of the end
of the product and the mattress.
(2) Most of the reported entrapment
fatalities involved one of the four zones
listed. In 214 out of 284 fatal incidents,
the entrapment location was identified
and all but six of these cases occurred
in one of the four zones of entrapment
tested in ASTM F3186–17. Based on
this analysis, it is likely that most of the
70 incidents for which there was
insufficient information to identify the
location of the entrapment also involved
one of these four zones.
(3) The Commission preliminarily
determines that modifications to the
voluntary standard are needed to
improve safety. Such modifications
include: provide additional definitions
for product assembly and installation to
ensure their consistent and
differentiated use throughout the
standard; add recommendations for
manufacturers to take into account the
range of mattress thicknesses to ensure
safe use of the product by the consumer
and provide testers with additional
guidance for selecting the mattress
thickness during the test setup; address
inconsistencies with stated dimensions
to ensure consistent dimensional
tolerances; provide additional clarity for
Zone 1 and 2 test setup and methods;
provide additional guidance for
identifying potential Zone 2 openings;
update the requirements for Zone 3
testing consistency; and correct
grammatical errors.
(4) The Commission preliminarily
determines that substantial compliance
with the voluntary standard is unlikely.
CPSC conducted two rounds of market
compliance testing to ASTM F3186–17:
the first round in 2018 and 2019, the
second round in 2021. In both rounds of
market compliance testing, no APBRs
met all requirements of ASTM F3186–
17. All products failed at least one
critical mechanical requirement, such as
retention strap performance, structural
integrity, and entrapment and all
products failed the labeling, warning,
and instructional requirements.
(i) Reasonable Relationship of
Benefits to Costs. (1) The benefits
expected from the proposed rule bear a
reasonable relationship to its cost. The
proposed rule is intended to reduce the
entrapment hazards associated with
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Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Proposed Rules
APBRs, and thereby reduce the societal
costs of the resulting injuries and
deaths. CPSC assumes that the number
of firms and APBR models in use will
tend to be stable in future years around
the values in 2022:12 firms and 65
models. The market for APBRs is
expected to grow at an average rate of
2.01 percent between 2024 and 2053 as
a result of an aging U.S. population.
Assuming the rates of incidents per
million APBRs stays constant, an
industry of this size would result in an
average of 32 deaths from entrapment
per year. At a value of a statistical life
(VSL) of $10.5 million (2021 dollars),
the annualized present value of the
potential societal costs of the proposed
rule therefore is $298.11 million.
(2) The requirements of the proposed
rule, with modifications, are expected to
address 92 percent of deaths caused by
entrapment and produce estimated
benefits of $266.99 million. Benefits
were assessed under three more
conservative scenarios derived from this
baseline efficacy, estimating benefits at:
75 percent, 50 percent, and 25 percent
of their potential value. Even under the
most conservative assumption that only
one quarter, or 25 percent of the
potential benefits are achieved, the net
benefits greatly exceed the costs of the
rule. The annualized benefits of the
proposed rule are estimated as follows:
at 75 percent—$200.24 million, 50
percent-$133.49 million, and 25
percent-$66.75 million, respectively.
The estimated annualized costs
associated with the proposed
requirements to prevent APBR hazards
is $2.01 million. This results in net
quantifiable net benefits of $198.23
million, $131.48 million, and $64.74
million on an annualized basis. On a per
product basis, the benefits of the
proposed rule are estimated between
$331.78 per APBR (75%), $221.19
(50%), and $110.59 per APBR (25%),
and the costs are $3.34 per APBR. All
these amounts are in 2021 dollars using
a discount rate of 3 percent.
(3) Injuries from entrapment and other
hazards on APBRs are not included in
the benefit-cost assessment because for
many incidents involving injuries, there
is not sufficient information to
determine whether they would fall
under the scope of this proposed rule.
However, the injuries are quantified in
a sensitivity analysis as a potential
upper limit to assess the benefits of this
proposed rule. The sensitivity analysis
used NEISS incidents and the Injury
Cost Model (ICM) to extrapolate and
generate national estimates for injuries
from entrapment treated in an ED or
other settings. The ICM calculated that
the aggregate number of nonfatal
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injuries in the United States from
entrapment from 2010 to 2019 was
125,121. Staff estimated that from the
total of these injuries, 79,563 were
treated in an outpatient setting (e.g.,
doctor’s office or clinic), 39,149 resulted
in ED treatment, and 6,409 resulted in
hospital admissions.
(j) Least-Burdensome Requirement
that Would Adequately Reduce the Risk
of Injury. The Commission considered
six alternatives to the proposed rule
including:
(i) Take no regulatory action;
(ii) Conduct a recall of APBRs instead
of promulgating a final rule;
(iii) Conduct an educational
campaign;
(iv) Ban APBRs from the market
entirely;
(v) Require enhanced safety warnings;
and
(vi) Longer effective date.
(4) Although most of these
alternatives may be a less burdensome
alternative to the proposed rule, the
Commission determines preliminarily
that none of the less burdensome
alternatives would adequately reduce
the risk of deaths and injuries associated
with APBRs that is addressed in the
proposed rule.
Alberta E. Mills,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2022–22692 Filed 11–8–22; 8:45 am]
BILLING CODE 6355–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 300
[REG–100719–21]
RIN 1545–BQ26
User Fees Relating to Enrolled
Actuaries; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correction to a notice of
proposed rulemaking and notice of
public hearing.
AGENCY:
This document contains a
correction to a notice of proposed
rulemaking and notice of public hearing
(REG–100719–21) published in the
Federal Register on October 5, 2022.
The notice of proposed rulemaking
contains proposed amendments to the
regulations relating to user fees for
enrolled actuaries.
DATES: Written or electronic comments
are being accepted and must be received
SUMMARY:
PO 00000
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67611
by December 19, 2022. Requests to
speak and outlines of topics to be
discussed at the public hearing
scheduled for January 9, 2023, at 10:00
a.m. EST must be received by December
19, 2022.
ADDRESSES: Commenters are strongly
encouraged to submit public comments
electronically. Submit electronic
submissions via the Federal
eRulemaking Portal at
www.regulations.gov (indicate IRS and
REG–100719–21) by following the
online instructions for submitting
comments. Once submitted to the
Federal eRulemaking Portal, comments
cannot be edited or withdrawn. The
Department of the Treasury (Treasury
Department) and the IRS will publish
any comment to the public docket for
public availability. Send paper
submissions to: CC:PA:LPD:PR (REG–
100719–21), Room 5203, Internal
Revenue Service, P.O. Box 7604, Ben
Franklin Station, Washington, DC
20044.
FOR FURTHER INFORMATION CONTACT:
Concerning the proposed regulation,
Carolyn M. Lee at (202) 317–6845;
concerning cost methodology, Michael
A. Weber at (202) 808–9738; and
concerning submission of comments,
the hearing, and the access code to
attend the hearing by telephone, Regina
Johnson, 202–317–6901 (not toll-free
numbers) or publichearings@irs.gov.
SUPPLEMENTARY INFORMATION:
Background
The proposed regulations and notice
of public hearing subject to this
correction are under section 9701 of
Title 31 of the United States Code.
Correction of Publication
Accordingly, the notice of proposed
rulemaking and notice of public hearing
(REG–100719–21) that is the subject of
FR Doc. 2022–21458, published on
October 5, 2022 (87 FR 60357), is
corrected to read as follows:
1. On page 60358, in the first column,
under the caption DATES, the paragraph
is corrected to read, ‘‘Electronic or
written comments must be received by
December 19, 2022. The public hearing
will be held by teleconference on
January 9, 2023, at 10:00 a.m. EST.
Requests to speak and outlines of topics
to be discussed at the public hearing
must be received by December 19, 2022.
The public hearing will be canceled if
no outlines are received by December
19, 2022. Requests to attend the public
hearing must be received by 5:00 p.m.
EST on January 5, 2023. The telephonic
hearing will be made accessible to
people with disabilities. Requests for
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| File Type | application/pdf |
| File Modified | 2022-11-09 |
| File Created | 2022-11-09 |